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PADELIPORFIN

March 1, 2018 8:45 am / Leave a comment

2D chemical structure of 759457-82-4

PADELIPORFIN

759457-82-4; 457P824,

RN: 759457-82-4
UNII: EEO29FZT86

3-[(2S,3S,12R,13R)-8-acetyl-13-ethyl-20-(2-methoxy-2-oxoethyl)-3,7,12,17-tetramethyl-18-(2-sulfoethylcarbamoyl)-2,3,12,13-tetrahydroporphyrin-22,24-diid-2-yl]propanoic acid;palladium(2+)

(SP-4-2)-[(7S,8S,17R,18R)-13-acetyl-18-ethyl-5-(2-methoxy-2-oxoethyl)-2,8,12,17-tetramethyl-3-[[(2-sulfoethyl)amino]carbonyl]-21H,23H-porphine-7-propanoato (4-)-kN21,kN22,kN23,kN24] palladate(2-)

Palladate(2-), [(7S,8S,17R,18R)-13-acetyl-18-ethyl-7,8-dihydro-5-(2-methoxy-2-oxoethyl)-2,8,12,17-tetramethyl-3-[[(2-sulfoethyl)amino]carbonyl]-21H,23H-porphine-7-propanoato(4-)-κN²¹,κN²²,κN²³,κN²⁴]-, (SP-4-2)-

Coordination Compound

Other Names

(SP-4-2)-[(7S,8S,17R,18R)-13-Acetyl-18-ethyl-7,8-dihydro-5-(2-methoxy-2-oxoethyl)-2,8,12,17-tetramethyl-3-[[(2-sulfoethyl)amino]carbonyl]-21H,23H-porphine-7-propanoato(4-)-κN²¹,κN²²,κN²³,κN²⁴]palladate(2-)

Molecular Formula:	C₃₇H₄₃N₅O₉PdS
Molecular Weight:	840.257 g/mol

Chemical Formula: C37H41K2N5O9PdS
Molecular Weight: 916.43

cas 698393-30-5

WST11; WST-11; WST 11; Stakel; padeliporfin; palladiumbacteriopheophorbide monolysine taurine.

Tookad : EPAR -Product Information

Tookad : EPAR – Summary for the public

(English only)

29/11/2017

Product details

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and:

Clinical stage T1c or T2a;
Gleason Score ≤ 6, based on high-resolution biopsy strategies;
PSA ≤ 10 ng/mL;
3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm³.

Name	Tookad
Agency product number	EMEA/H/C/004182
Active substance	padeliporfin di-potassium
International non-proprietary name(INN) or common name	padeliporfin
Therapeutic area	Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code	L01XD07
Additional monitoring	This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Marketing-authorisation holder	STEBA Biotech S.A
Revision	0
Date of issue of marketing authorisation valid throughout the European Union	10/11/2017

Contact address:

STEBA Biotech S.A
7 place du theatre
L-2613 Luxembourg
Luxembourg

Padeliporfin is a vascular-acting photosensitizer consisting of a water-soluble, palladium-substituted bacteriochlorophyll derivative with potential antineoplastic activity. Upon administration, paldeliporfin is activated locally when the tumor bed is exposed to low-power laser light; reactive oxygen species (ROS) are formed upon activation and ROS-mediated necrosis may occur at the site of interaction between the photosensitizer, light and oxygen. Vascular-targeted photodynamic therapy (VTP) with padeliporfin may allow tumor-site specific cytotoxicity while sparing adjacent normal tissues.

WST-11 (Stakel) is a water-soluble bacteriochlorophyll (chemical structure shown below) derivative coordinated with palldium, which has maximum absorption wavelength in the near infrared (753 nm) and rapid clearance from the body ( t 1/2 = 0.37 hour for a 10-mg/kg drug dose in the rat and t 1/2 = 0.51 hour, 1 hour, and 2.65 hours for 1.25-, 2.5-, and 5-mg/kg drug doses, respectively. It binds to serum albumin and has potent antivascular activity through the generation of hydroxyl radicals when stimulated by the proper light wavelength.

Image result for PADELIPORFIN

Photodynamic therapy (PDT) is a non-surgical treatment of tumors in which non-toxic drugs and non-hazardous photosensitizing irradiation are combined to generate cytotoxic reactive oxygen species in situ. This technique is more selective than the commonly used tumor chemotherapy and radiotherapy. To date, porphyrins have been employed as the primary photosensitizing agents in clinics. However, current sensitizers suffer from several deficiencies that limit their application, including mainly: (1) relatively weak absorption in the visible spectral range which limits the treatment to shallow tumors; (2) accumulation and long retention of the sensitizer in the patient skin, leading to prolonged (days to months) skin phototoxicity; and (3) small or even no differentiation between the PDT effect on illuminated tumor and non-tumor tissues. The drawbacks of current drugs inspired an extensive search for long wavelength absorbing second-generation sensitizers that exhibit better differentiation between their retention in tumor cells and skin or other normal tissues.

In order to optimize the performance of the porphyrin drugs in therapeutics and diagnostics, several porphyrin derivatives have been proposed in which, for example, there is a central metal atom (other than Mg) complexed to the four pyrrole rings, and/or the peripheral substituents of the pyrrole rings are modified and/or the macrocycle is dihydrogenated to chlorophyll derivatives (chlorins) or tetrahydrogenated to bacteriochlorophyll derivatives (bacteriochlorins).

Due to their intense absorption in favorable spectral regions (650-850 nm) and their ready degradation after treatment, chlorophyll and bacteriochlorophyll derivatives have been identified as excellent sensitizers for PDT of tumors and to have superior properties in comparison to porphyrins, but they are less readily available and more difficult to handle.

Bacteriochlorophylls are of potential advantage compared to the chlorophylls because they show intense near-infrared bands, i.e. at considerably longer wavelengths than chlorophyll derivatives.

The spectra, photophysics, and photochemistry of native bacteriochlorophylls (Bchls) have made them optimal light-harvesting molecules with clear advantages over other sensitizers presently used in PDT. In particular, these molecules have a very high extinction coefficient at long wavelengths (λ_max=760-780 nm, ε=(4-10)xl0⁴ M^-1cm^-1), where light penetrates deeply into tissues. They also generate reactive oxygen species (ROS) at a high quantum yield (depending on the central metal).

Under normal delivery conditions, i.e. in the presence of oxygen at room temperature and under normal light conditions, the BChl moieties are labile and have somewhat lower quantum yields for triplet state formation, when compared with, e.g., hematoporphyrin derivative (HPD). However, their possible initiation of biological redox reactions, favorable spectral characteristics and their ready degradation in vivo result in the potential superiority of bacteriochlorophylls over other compounds, e.g. porphyrins and chlorophylls, for PDT therapy and diagnostics and for killing of cells, viruses and bacteria in samples and in living tissue. Chemical modification of bacteriochlorophylls is expected to further improve their properties, but this has been very limited due to lack of suitable methods for the preparation of such modified bacteriochlorophylls .

The biological uptake and PDT efficacy of metal-free derivatives of Bchl have been studied with the objective to manipulate the affinity of the sensitizers to the tumor cellular compartment. Cardinal to this approach is the use of highly lipophilic drugs that may increase the accumulation of the drug in the tumor cells, but also renders its delivery difficult. In addition, the reported biodistribution shows significant phototoxic drug levels in non-tumor tissues over prolonged periods (at least days) after administering the drug.

In applicant’s previous Israel Patent No. 102645 and corresponding EP 0584552, US 5,726,169, US 5,726,169, US 5,955,585 and US 6,147,195, a different approach was taken by the inventors. Highly efficient anti- vascular sensitizers that do not extravasate from the circulation after administration and have short lifetime in the blood were studied. It was expected that the inherent difference between vessels of normal and abnormal tissues such as tumors or other tissues that rely on neovessels, would enable relatively selective destruction of the abnormal tissue. Hence, it was aimed to synthesize Bchl derivatives that are more polar and, hence, have better chance to stay in the vascular compartment, where they convey the primary photodynamic effect. To this end, the geranylgeranyl residue at the C-17 position of Bchl a (Compound 1, depicted in Scheme 1 herein) has been replaced by various residues such as amino acids, peptides, or proteins, which enhance the sensitizer hydrophilicity. One particular derivative, Bchl-Ser (Scheme 1, Compound 1, wherein R is seryl), was found to be water-soluble and highly phototoxic in cell cultures. Following infraperitoneal injection, the Bchl-Ser cleared from the mouse blood and tissues bi-exponentially in a relatively short time (t_1/2~2 and 16 h, respectively). Clearance from the circulation was even faster following intravenous injection. Under the selected treatment protocol (light application within minutes after drug injection), phototoxicity was predominantly conferred to the tumor vasculature (Rosenbach-

Belkin et al., 1996; Zilberstein et al., 2001 and 1997). However, unfortunately, like native Bchl, the Bchl-Ser derivative undergoes rapid photo-oxidation, forming the corresponding 2-desvinyl-2-acetyl-chlorophyllide ester and other products.

To increase the stability of the Bchl derivatives, the central Mg atom was replaced by Pd in the later applicant’s PCT Publication WO 00/33833 and US 6,569,846. This heavy atom was previously shown to markedly increase the oxidation potential of the Bchl macrocycle and, at the same time, to greatly enhance the intersystem-crossing (ISC) rate of the molecule to its triplet state. The metal replacement was performed by direct incorporation of Pd²⁺ ion into a Bpheid molecule, as described in WO 00/33833. Based on the pigment biodistribution and pharmacokinetics, it was assumed that the derivative Pd-Bpheid remained in the circulation for a very short time with practically no extravasation to other tissues, and is therefore a good candidate for vascular-targeting PDT that avoids skin phototoxicity. The treatment effect on the blood vessels was demonstrated by intravital microscopy of treated blood vessels and staining with Evans-Blue. Using a treatment protocol with a minimal drug-to-light interval, Pd-Bpheid (also designated Tookad) was found to be effective in the eradication of different tumors in mice, rats and other animal models and is presently entering Phase I/II clinical trials in patients with prostate cancer that failed radiation therapy (Chen et al, 2002; Schreiber et al., 2002; Koudinova et al., 2003).

Because of its low solubility in aqueous solutions, the clinical use of Pd-Bpheid requires the use of solubilizing agents such as Cremophor that may cause side effects at high doses. It would be highly desirable to render the Pd-Bpheid water-soluble while retaining its physico-chemical properties. Alternatively, it would be desirable to prepare Bchl derivatives that are cytophototoxic and, at the same time, more water-soluble than Pd-Bpheid itself. Such water solubility is expected to further enhance the drug retention in the circulation and, thereby, the aforementioned selectivity. In addition, having no need to use carriers such as detergents or lyposomes, may prevent side effects.

SYNTHESIS

START FROM CAS 17499-98-8, Phorbine, magnesium deriv., Bacteriochlorophyll a_P

PADELIPORFIN

Paper

Novel water-soluble bacteriochlorophyll derivatives for vascular-targeted photodynamic therapy: Synthesis, solubility, phototoxicity and the effect of serum proteins
Photochemistry and Photobiology (2005), 81, (July/Aug.), 983-993

PAPER

Journal of Medicinal Chemistry (2014), 57(1), 223-237

With the knowledge that the dominant photodynamic therapy (PDT) mechanism of 1a (WST09) switched from type 2 to type 1 for 1b (WST11) upon taurine-driven E-ring opening, we hypothesized that taurine-driven E-ring opening of bacteriochlorophyll derivatives and net-charge variations would modulate reactive oxygen species (ROS) photogeneration. Eight bacteriochlorophyll a derivatives were synthesized with varying charges that either contained the E ring (2a–5a) or were synthesized by taurine-driven E-ring opening (2b–5b). Time-dependent density functional theory (TDDFT) modeling showed that all derivatives would be type 2 PDT-active, and ROS-activated fluorescent probes were used to investigate the photogeneration of a combination of type 1 and type 2 PDT ROS in organic- and aqueous-based solutions. These investigations validated our predictive modeling calculations and showed that taurine-driven E-ring opening and increasing negative charge generally enhanced ROS photogeneration in aqueous solutions. We propose that these structure–activity relationships may provide simple strategies for designing bacteriochlorins that efficiently generate ROS upon photoirradiation.

Modulation of Reactive Oxygen Species Photogeneration of Bacteriopheophorbide a Derivatives by Exocyclic E-Ring Opening and Charge Modifications

Áron Roxin†‡, Juan Chen‡, Andrew S. Paton§, Timothy P. Bender§, and Gang Zheng *†‡

^† Department of Pharmaceutical Sciences, Leslie L. Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2, Canada

^‡ Ontario Cancer Institute and Techna Institute, UHN, 101 College Street, Toronto, Ontario M5G 1L7, Canada

^§ Department of Chemical Engineering and Applied Chemistry, University of Toronto, 200 College Street, Toronto, Ontario M5S 3E5, Canada

J. Med. Chem., 2014, 57 (1), pp 223–237

DOI: 10.1021/jm401538h

*Tel: 416-581-7666. Fax 416-581-7667. E-mail: gzheng@uhnresearch.ca.

Palladium 3¹-Oxo-15-methoxycarbonylmethyl-rhodobacteriochlorin 13′-(2-Sulfethyl)amide (1b)

……………… The dried crude product was dissolved in 200 μL of DMSO and purified by reverse-phase HPLC. The product was quantified spectrophotometrically, the identity was characterized using ESI+MS and UV–vis spectroscopy, and the purity was found to be >95% using HPLC–MS. This yielded 0.21 mg (250 nmol) of 1b(0.7% yield). ESI+MS: [M]⁺ = 840 m/z. UV–vis (MeOH, λ_max): 748, 517, 385, 332 nm.

PATENT

WO 2004045492

CHEMICAL EXAMPLES

Example 1. Palladium 3¹-oxo-15-methoxycarbonylmethyl-Rhodobacteriochlorin 13¹-(2-sulfoethyl)amide dipotassium salt ( Compound 4)

Nine hundred and thirty five (935) mg of Pd-Bpheid (3) were dissolved in a 1 L round bottom flask with 120 ml of DMSO while stirring under Argon (bubbled in the solution). Taurine (1288 mg) was dissolved in 40 ml of 1M K₂HPO₄ buffer, and the pH of the solution was adjusted to 8.2 (with HCl ). This aqueous solution was added into the DMSO solution while stirring, and the Argon was bubbled in the solution for another 20 minutes. Then the reaction mixture was evaporated at 30°C for 3.5 hours under ~2 mbar and then for another 2 hours at 37°C to a complete dryness. The dry solids were dissolved in 300 ml of MeOH and the colored solution was filtered through cotton wool to get rid of buffer salts and taurine excess.

The progress of the reaction was determined by TLC (R_f of unreacted Pd- Bpheid is 0.8-0.85 and of the reaction (aminolysis) product is 0.08-0.1) and by following the optical absorption spectrum of the reaction mixture after liophylization and resolubihzation in MeOH. The absorption spectrum was characterized by a Q_ytransition shift from 756 nm (for Pd-Bpheid) to 747 nm (for the product 4) and by Q_x shift from 534 nm of Pd-Bpheid to 519 nm (of the product 4). The MeOH was evaporated and the product 4 was purified by HPLC with ODS-A 250X20 S10P μm column (YMC, Japan). Solvent A: 95% 0.005 M phosphate buffer, pH 8.0 and 5% MeOH. Solvent B: 100% MeOH. The dry solid was dissolved in 42 ml of distilled water and injected in portions of 1.5 ml each .

The elution profile is described in Table 1. The product 4_(Scheme 1, see below) was eluted and collected at ~ 9-11 minutes. The main impurities, collected after at 4-7 min (ca 5-10%), corresponded to byproduct(s) with the proposed structure 7. Peaks at 22-25 min (ca 2-5%) possibly corresponded to the iso-form of the main product 4 and untreated Pd-Bpheid residues.

The solvent (aqueous methanol) was evaporated under reduced pressure. Then, the purified product 4 ]was re-dissolved in ~150 ml MeOH and filtered through cotton wool. The solvent was evaporated again and the solid pigment 4 was stored under Ar in the dark at -20°C. The reaction yield: ~90% (by weight, relative to 3).

The structure of product 4 was confirmed by electrospray mass spectroscopy. (ESI-MS, negative mode, Fig.2), (peaks at 875 (M–K-H), 859 (M–2K-H+Na), 837 (M–2K), 805 (M2K-H-OMe), 719) and 1H-NMR spectrum (Fig. 4 in MeOH-d₄). Table 4 provides the shifts (in ppm units) of the major NMR peaks.

Optical absorption (UN-VIS) spectrum (MeOH): λ, 747 (1.00), 516 (0.13), 384 (0.41), 330 (0.50); ε₇₄₇ (MeOH) is 1.2 x 10⁵ mol^-1 cm ^_1.

ΝMR (MeOH-d₄): 9.38 (5-H, s), 8.78 (10-H, s), 8.59 (20-H, s), 5.31 and 4.95 (15¹-CH₂, dd), 4.2-4.4 (7,8,17,18-H, m), 3.88 (15³-Me, s), 3.52 (2¹-Me, s), 3.19 (12¹ -Me, s), 3.09 (3²-Me, s), 1.92-2.41, 1.60-1.75 (17¹, 17²-CH₂, m), 2.19 (8¹-CH₂, m), 1.93 (7¹-Me, d), 1.61 (18¹-Me, d), 1.09 (8²-Me, t), 3.62, 3.05 (CH₂‘s of taurine).

Octanol/water partition ratio is 40:60.

Example 2. Preparation of 3¹-oxo-15-methoxycarbonylmethyl- Rhodobacteriochlorin 13¹-(2-sulfoethyl)amide dipotassium salt (Compound 5) One hundred and sixty (160) mg of taurine were dissolved in 5 ml of 1M

K₂HPO₄ buffer, and the pH of the solution was adjusted to 8.2. This solution was added to 120 mg of compound 2 dissolved in 15 ml of DMSO, and the reaction and following purification were analogous to those described in previous Example.

Absorption spectrum (MeOH): λ, 750 (1.00), 519 (0.30), 354 (1.18) nm.

ESI-MS (-): 734 (M–2K).

ΝMR (MeOH-d₄): 9.31 (5-H, s), 8.88 (10-H, s), 8.69 (20-H, s), 5.45 and 5.25 (15¹-CH₂, dd), 4.35 (7,18-H, m), 4.06 (8,17-H, m), 4.20 and 3.61 (2-CH₂, m of taurine), 3.83 (15³-Me, s), 3.63 (2¹-Me, s), 3.52 (3-CH₂, m oftaurine), 3.33 (12¹-Me, s), 3.23 (3²-Me, s), 2.47 and 2.16 (17¹-CH₂, m), 2.32 and 2.16 (8¹-CH₂, m), 2.12 and 1.65 (17²-CH₂, m), 1.91 (7¹-Me, d), 1.66 (18¹– Me, d), 1.07 (8²-Me, t).

Octanol/water partition ratio is 60:40.

Example 3. Preparation of copper(II) 3¹-oxo-15-methoxycarbonylmethyl- Rhodobacteriochlorin 13¹-(2-sulfoethyl)amide dipotassium salt (Compound 10)

Fifty (50) mg of compound 5 of Example 2 and 35 mg of copper (II) acetate were dissolved in 40 ml of methanol, and argon was bubbled into solution for 10 minutes. Then 500 mg of palmitoyl ascorbate was added, and the solution was stirred for 30 min. The absorption spectrum was characterized by a Q_y transition shift from 750 nm (for 5) to 768 nm (for the product 10) and by Q_x shift from 519 nm of 5 to 537 nm (of the product 10). Then the reaction mixture was evaporated, re-dissolved in acetone and filtered through cotton wool to get rid of acetate salt excess. The acetone was evaporated and the product was additionally purified by HPLC at the conditions mentioned above with the elution profile, described in Table 2.

The solvent (aqueous methanol) was evaporated under reduced pressure. Then, the purified pigment 10 was re-dissolved in methanol and filtered through cotton wool. The solvent was evaporated again and the solid pigment 10 was stored under Ar in the dark at -20°C. Reaction yield: -90%.

Absorption spectrum (MeOH): λ, 768 (1.00), 537 (0.22), 387 (0.71) and 342 (0.79) nm.

ESI-MS (-): 795 (M–2K).

Octanol/water partition ratio is 40:60.

Example 4. Preparation of zinc 3¹-oxo-15-methoxycarbonylmethyl-Rhodobacteriochlorin 13¹-(2-sulfoethyl)amide dipotassium salt (Compound 11)

Zn insertion into compound 5 was carried out with Zn acetate in acetic acid as previously described (US Patent No. 5,726,169). Final purification was carried out by HPLC in the same conditions as for compound 5 in Example 2 above.

Absorption spectrum (MeOH): λ, 762 (1.00), 558 (0.26), 390 (0.62) and 355 (0.84) nm.

Octanol/water partition ratio is 50:50.

Example 5. Preparation of manganese(III) 3¹-oxo-15-methoxycarbonylmethyl-Rhodobacteriochlorin 13¹-(2-sulfoethyl)amide dipotassium salt (Compound 12)

Mn insertion into compound 5 was carried out with Zn acetate in acetic acid as previously described (WO 97/19081; US 6,333,319) with some modifications. Thus, fifty (50) mg of compound 5 in 10 ml of DMF were stirred with 220 mg of cadmium acetate and heated under argon atmosphere at 110°C about 15 min (Cd-complex formation is monitored by shifting Q_x transition absorption band from 519 to 585 nm in acetone). Then the reaction mixture was cooled and evaporated. The dry residue was re-dissolved in 15 ml of acetone and stirred with manganese (II) chloride to form the Mn(III)-product 12. The product formation is monitored by shifting Q_x transition band from 585 to 600 nm and Q_y transition band from 768 to 828 nm in acetone. The acetone was evaporated and the product 12 was additionally purified by HPLC in the conditions mentioned in Example 2 above with the elution profile described in Table 3 below where the] solvent system consists of: A – 5% aqueous methanol, B -methanol.

The solvent (aqueous methanol) was evaporated under reduced pressure and the solid pigment 12 was stored under Ar in the dark at -20°C.

Absorption spectrum (MeOH): λ, 828 (1.00), 588 (0.32) and 372 (0.80) nm. Octanol/water partition ratio is 5:95.

Example 6. Preparation of palladium bacteriopheophorbide a 17 -(3-sulfo-1-oxy- succinimide)ester sodium salt (Compound 6)

Fifty (50) mg of Pd-Bpheid (compound 2), 80 mg of N-hydroxy- sulfosuccinimide (sulfoNHS) and 65 mg of 1-(3-dimethylaminopropyl)-3- ethylcarbodiimide (EDC) were mixed in 7 ml of dry DMSO for overnight at room temperature. Then the solvent was evacuated under reduced pressure. The dry residue was re-dissolved in chloroform (ca. 50 ml), filtered from insoluble material, and evaporated. The conversion was ab. 95%) (TLC). The product 6 was used later on without further chromatographic purification. ESI-MS (-): 890 (M–Na).

NMR (CDCl₃): 9.19 (5-H, s), 8.49 (10-H, s), 8.46 (20-H, s), 5.82 (13²-H, s), 4.04- 4.38 (7,8,17,18-H, m), 3.85 (13⁴-Me, s), 3.47 (2¹-Me, s), 3.37 (^-Me, s), 3.09 (3²– Me, s), 1.77 (7¹-Me, d), 1.70 (lδ’-Me, d), 1.10 (8²-Me, t), 4.05 (CH₂ of sNHS), 3.45 (CH ofs NHS).

Example 7. Preparation of palladium bacteriopheophorbide a 17³-(3-sulfopropyl) amide potassium salt (Compound 7)

Ten (10) mg of compound 6 in 1 ml of DMSO was mixed with 20 mg of homotaurine (3-amino-1-propane-sulfonic acid) in 1 ml of 0.1 M K-phosphate buffer, pH 8.0 for overnight. Then the reaction mixture was partitioned in chloroform/water. The organic layer was dried over anhydrous sodium sulfate and evaporated. The dry residue was re-dissolved in chloroform-methanol (19:1) and applied to a chromatographic column with silica. The product 7 was obtained with chloroform-methanol (4:1) elution. The yield was about 80-90%.

ESI-MS (-): 834 (M-K) m/z.

NMR (MeOH-d₄): 9.16 (5-H, s), 8.71 (10-H, s), 8.60 (20-H, s), 6.05 (13²-H, s), 4.51, 4.39, 4.11, 3.98 (7,8,17,18-H, all m), 3.92 (13⁴-Me, s), 3.48 (2¹-Me, s), 3.36 (12¹-Me, s), 3.09 (3²-Me, s), 2.02-2.42 (17¹ arid 17²-CH₂, m), 2.15 ( 8¹-CH₂, q), 1.81 (7¹-Me, d), 1.72 (18¹-Me, d), 1.05 (8²-Me, t), 3.04, 2.68, and 2.32 (CH₂‘s of homotaurine, m).

Example 8. Preparation of palladium 3¹-oxo-15-methoxycarbonylmethyl-Rhodo-bacteriochlorin 13 ,17 -di(3-sulfopropyl)amide dipotassium salt (Compound 8)

Ten (10) mg of compound 6 or 7 were dissolved in 3 ml of DMSO, mixed with 100 mg of homotaurine in 1 ml of 0.5 M K-phosphate buffer, pH 8.2, and incubated overnight at room temperature. The solvent was then evacuated under reduced pressure as described above, and the product 8 was purified on HPLC. Yield: 83%.

Absorption spectrum (MeOH): 747 (1.00), 516 (0.13), 384 (0.41), 330 (0.50), ε₇₄₇ =1.3×10⁵ modern^-1.

ESI-MS(-):1011 (M–K), 994 (M–2K+Na),972 (M–2K), 775 (M–2K-CO₂Me-homotaurineNHCH₂CH₂CH₂SO₃), 486 ([M-2K]/2)

NMR (MeOH-d₄): 9.35 (5-H, s), 8.75 (10-H, s), 8.60 (20-H, s), 5.28 and 4.98 (15^-1-CH₂, dd), 4.38, 4.32, 4.22, 4.15 (7,8,17,18-H, all m), 3.85 (15^~3-Me, s), 3.51 (2¹-Me, s), 3.18 (12¹-Me, s), 3.10 (3²-Me, s 2.12-2.41 (17¹-CH₂, m), 2.15-2.34 (8¹-CR₂, m), 1.76-2.02 (17²-CH₂, m), 1.89 (7¹-Me, d), 1.61 (lδ^Me, d), 1.07 (8²-Me, t). 3.82, 3.70,

3.20, 3.10, 2.78, 2.32, 1.90 (CH₂‘s of homotaurine at C-13¹ and C-17³)

Example 9. Palladium 3¹-(3-sulfopropylimino)-15-methoxycarbonylmethyl-Rhodo-bacteriochlorin 13¹,17³-di(3-sulfopropyl)amide tripotassium salt (Compound 9)

Compound 9 was obtained from HPLC as a minor product during synthesis of 8.

Absorption spectrum (MeOH): 729 (1.00), 502 (0.10), 380 (0.69), 328 (0.57).

ESI-MS (30.4.2000): 1171 (M-K+H), 1153 (M–2K-H+Na), 1131 (M-2K), 566 ([M-K]/2), 364 ([M-3K]/3).

NMR (MeOH-d₄): 8.71 (1H), 8.63 (1.5H), 8.23 (0.5H) (5-, 10- and 20-H, all-m), 5.30 and 4.88 (15¹-CH₂, dd), 4.43 and 4.25 (7,8,17,18-H, m), 3.85 (15^~3-Me, s), 3.31 (2¹-Me, s), 3.22 (12¹-Me, s), 3.17 (3²-Me, m), 1.89-2.44 (17¹ and 17²-CH₂, m), 2.25 (8¹-CH₂, m), 1.91 (7¹-Me, s), 1.64 (18¹– Me, s), 1.08 (8²-Me, t), 4.12, 3.56, 3.22, 3.16, 2.80 and 2.68 (CH₂‘s of homotaurine).

Example 10. Palladium 3¹-oxo-15-methoxycarbonylmethyl-Rhodobacteriochlorin 13¹-(2-sulfoethyl)amide, 17³-(N-immunoglobulin G)amide potassium salt (Compound 13)

Ten (10) mg of compound 4 were reacted with 20 mg of sulfo-NHS and 15 mg of EDC in 1 ml of dry DMSO for 1 hour at room temperature, then rabbit IgG (0.6 mg) in PBS (2.5 ml) was added, and the mixture was further incubated overnight at room temperature. The mixture was evaporated to dryness, then re-dissolved in 1 ml of PBS and loaded on Sephadex G-25 column equilibrated with PBS. A colored band was eluted with 4-5 ml of PBS. The pigment/protein ratio in the obtained conjugate 13 was determined by optical density at 753 and 280 mn, respectively, and varied between 0.5/1 to 1/1 of pigment 13/protein.

Example 11. Preparation of palladium 3¹-oxo-15-methoxycarbonylmethyl-Rhodobacteriochlorin 13¹-(2-carboxyethyl)amide dipotassium salt (Compound

The preparation and purification of the title compound 14 were carried out as described in Example 2, by reaction of compound 2 with 3-aminopropionic acid (β-alanine) (150 mg) instead of taurine. Yield: 85%.

Example 12. Preparation of palladium 3¹-oxo-15-methoxycarbonylmethyl-Rhodobacteriochlorin 13¹-(3-phosphopropyl)amide tripotassium salt (Compound

15)

The preparation and purification of the title compound 15 were carried out as described in Example 2, by reaction of compound 2 with 3 -amino- 1-propanephosphonic acid (180 mg) instead of taurine. Yield: 68%.

Example 13. Palladium 3¹-(3-sulfopropylamino)-15-methoxycarbonylmethyl-Rhodobacteriochlorin 13¹,17³-di(3-sulfopropyl)amide tripotassium salt (Compound 16)

For reduction of the imine group in 3¹-(3-sulfopropylimino) to the correspondent 3¹-(3-sulfopropylamino) group, compound 9 (8 mg) was reacted by stirring with sodium cyanoborohydride (15 mg) in 5 ml of methanol overnight at room temperature. Then the reaction mixture was treated with 0.05 M HCl (5 ml), neutralized with 0.01 M KOH, and evaporated. The title product 16 was purified using HPLC conditions as described in Example 2. Yield: 80-90%).

PATENT

US 7947672

REFERENCES

1: Kessel D, Price M. Evaluation of DADB as a Probe for Singlet Oxygen Formation during Photodynamic Therapy. Photochem Photobiol. 2012 Feb 2. doi: 10.1111/j.1751-1097.2012.01106.x. [Epub ahead of print] PubMed PMID: 22296586.

2: Betrouni N, Lopes R, Puech P, Colin P, Mordon S. A model to estimate the outcome of prostate cancer photodynamic therapy with TOOKAD Soluble WST11. Phys Med Biol. 2011 Aug 7;56(15):4771-83. Epub 2011 Jul 13. PubMed PMID: 21753234.

3: Chevalier S, Anidjar M, Scarlata E, Hamel L, Scherz A, Ficheux H, Borenstein N, Fiette L, Elhilali M. Preclinical study of the novel vascular occluding agent, WST11, for photodynamic therapy of the canine prostate. J Urol. 2011 Jul;186(1):302-9. Epub 2011 May 20. PubMed PMID: 21600602.

4: Dandler J, Wilhelm B, Scheer H. Photochemistry of bacteriochlorophylls in human blood plasma: 1. Pigment stability and light-induced modifications of lipoproteins. Photochem Photobiol. 2010 Mar-Apr;86(2):331-41. Epub 2009 Nov 23. PubMed PMID: 19947966.

5: Dandler J, Scheer H. Inhibition of aggregation of [Pd]-bacteriochlorophyllides in mesoporous silica. Langmuir. 2009 Oct 20;25(20):11988-92. PubMed PMID: 19772311.

6: Ashur I, Goldschmidt R, Pinkas I, Salomon Y, Szewczyk G, Sarna T, Scherz A. Photocatalytic generation of oxygen radicals by the water-soluble bacteriochlorophyll derivative WST11, noncovalently bound to serum albumin. J Phys Chem A. 2009 Jul 16;113(28):8027-37. PubMed PMID: 19545111.

7: Moore CM, Pendse D, Emberton M. Photodynamic therapy for prostate cancer–a review of current status and future promise. Nat Clin Pract Urol. 2009 Jan;6(1):18-30. Review. PubMed PMID: 19132003.

8: Preise D, Oren R, Glinert I, Kalchenko V, Jung S, Scherz A, Salomon Y. Systemic antitumor protection by vascular-targeted photodynamic therapy involves cellular and humoral immunity. Cancer Immunol Immunother. 2009 Jan;58(1):71-84. Epub 2008 May 17. PubMed PMID: 18488222.

9: Fleshker S, Preise D, Kalchenko V, Scherz A, Salomon Y. Prompt assessment of WST11-VTP outcome using luciferase transfected tumors enables second treatment and increase in overall therapeutic rate. Photochem Photobiol. 2008 Sep-Oct;84(5):1231-7. Epub 2008 Apr 8. PubMed PMID: 18399928.

10: Berdugo M, Bejjani RA, Valamanesh F, Savoldelli M, Jeanny JC, Blanc D, Ficheux H, Scherz A, Salomon Y, BenEzra D, Behar-Cohen F. Evaluation of the new photosensitizer Stakel (WST-11) for photodynamic choroidal vessel occlusion in rabbit and rat eyes. Invest Ophthalmol Vis Sci. 2008 Apr;49(4):1633-44. PubMed PMID: 18385085.

11: Fabre MA, Fuseau E, Ficheux H. Selection of dosing regimen with WST11 by Monte Carlo simulations, using PK data collected after single IV administration in healthy subjects and population PK modeling. J Pharm Sci. 2007 Dec;96(12):3444-56. PubMed PMID: 17854075.

12: Brandis A, Mazor O, Neumark E, Rosenbach-Belkin V, Salomon Y, Scherz A. Novel water-soluble bacteriochlorophyll derivatives for vascular-targeted photodynamic therapy: synthesis, solubility, phototoxicity and the effect of serum proteins. Photochem Photobiol. 2005 Jul-Aug;81(4):983-93. PubMed PMID: 15839743.

13: Mazor O, Brandis A, Plaks V, Neumark E, Rosenbach-Belkin V, Salomon Y, Scherz A. WST11, a novel water-soluble bacteriochlorophyll derivative; cellular uptake, pharmacokinetics, biodistribution and vascular-targeted photodynamic activity using melanoma tumors as a model. Photochem Photobiol. 2005 Mar-Apr;81(2):342-51. PubMed PMID: 15623318.

14: Plaks V, Posen Y, Mazor O, Brandis A, Scherz A, Salomon Y. Homologous adaptation to oxidative stress induced by the photosensitized Pd-bacteriochlorophyll derivative (WST11) in cultured endothelial cells. J Biol Chem. 2004 Oct 29;279(44):45713-20. Epub 2004 Aug 31. PubMed PMID: 15339936.

////////PADELIPORFIN, WST11, WST-11, WST 11, Stakel, padeliporfin, palladiumbacteriopheophorbide monolysine taurine, EU 2017, EMA 2017

CCC1C(C2=NC1=CC3=C(C(=C([N-]3)C(=C4C(C(C(=N4)C=C5C(=C(C(=C2)[N-]5)C(=O)C)C)C)CCC(=O)O)CC(=O)OC)C(=O)NCCS(=O)(=O)O)C)C.[Pd+2]

Novel Drug Approvals for 2017, A Review/Compilation

February 17, 2018 4:11 am / Leave a comment

CDSCO Image result for FDA EMA

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO, Novel Drug Approvals for 2017, A Review Compilation (USFDA, EMA, PMDA, CDSCO).

Any errors in this compilation, email amcrasto@gmail.com, Call +919323115463

Some gaps will be filled up soon keep watching……………..

INDEX, NAME (click on the title, it contains link)

SECTION A; USFDA Approvals

6 BENRALIZUMAB

17 DURVALUMAB

24 GUSELKUMAB

25 INOTUZUMAB OZOGAMICIN

26 LATANOPROSTENE

27 LETERMOVIR

28 MACIMORELIN ACETATE

36 OZENOXACIN

40 SARILUMAB

41 SECNIDAZOLE

48 VESTRONIDASE ALFA-VJBK

49 VELPATASVIR

50 VOXILAPREVIR

INDEX, FORMULATION NAME

USFDA

•Aliqopa (COPANLISIB) to treat adults with relapsed follicular lymphoma — a slow-growing type of nonHodgkin lymphoma (a cancer of the lymph system) — who have received at least two prior systemic therapies;

• ALUNBRIG, BRIGATINIB, To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib

• Austedo, Deutetrabenazine For the treatment of chorea associated with Huntington’s disease

• Bavencio (avelumab) for the treatment of patients 12 years and older with a rare and aggressive form of cancer called metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy;

•BAXDELLA, Delafloxacin, BACTERIAL INFECTIONS

• Benznidazole to treat children ages 2 to 12 years with Chagas disease, a parasitic infection that can cause serious heart illness after years of infection, and can also affect swallowing and digestion. This is the first treatment approved in the United States for this rare disease;

• Besponsa (inotuzumab ozogamicin) for the treatment of adults with a type of cancer of the blood called relapsed or refractory B-cell precursor acute lymphoblastic leukemia;

•BEVYXXA, BETRIXABAN, For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness

• BRINEURA, CERLIPONASE ALFA, To treat a specific form of Batten disease

• Calquence (ACALABRUTINIB) to treat adults with mantle cell lymphoma who have received at least one prior therapy. Mantle cell lymphoma is a particularly aggressive cancer;

• DUPIXENT, (DUPILUMAB) To treat adults with moderate-to-severe eczema (atopic dermatitis)

• Emflaza (deflazacort) to treat patients age 5 years and older with Duchenne muscular dystrophy, a rare genetic disorder that causes progressive muscle deterioration and weakness;

• FASENRA, BENRALIZUMAB, For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype

• Giapreza (angiotensin II), for the treatment of hypotension in adults with distributive or vasodilatory shock (dangerously low blood pressure despite adequate heart function) whose blood pressure remains low despite receiving fluids and treatment with drugs called vasopressors;

• HEMLIBRA EMICIZUMAB To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.

• Idhifa (enasidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia, a form of blood cancer, who have a specific genetic mutation;

• IMFINZI, DURVALUMAB To treat patients with locally advanced or metastatic urothelial carcinoma

• Ingrezza (valbenazine) to treat adults with tardive dyskinesia, a side effect of some antipsychotic medications whereby patients can experience uncontrollable stiff, jerky movements of their face and body, and other uncontrolled movements such as eye-blinking, sticking out the tongue, and arm-waving;

• KEVZARA SARILUMAB, RHEUMATOID ARTHRITIS

• KISQALI, RIBOCICLIB, To treat postmenopausal women with a type of advanced breast cancer

• Macrilen macimorelin acetate, For the diagnosis of adult growth hormone deficiency

• Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease, as well as those who are on hemodialysis;

• Mepsevii (vestronidase alfa-vjbk) to treat patients with Sly syndrome or mucopolysaccharidosis type 7 – a rare genetic disorder where an enzyme deficiency results in skeletal abnormalities, developmental delay, enlarged liver and spleen, and narrowed airways, which can lead to respiratory infections;

• Nerlynx (neratinib) for the extended adjuvant treatment — a form of therapy administered after an initial treatment to further lower the risk of the cancer coming back — of early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer;

• OCREVUS, OCRELIZUMAB, To treat patients with relapsing and primary progressive forms of multiple sclerosis

• OZEMPIC SEMAGLUTIDE To improve glycemic control in adults with type 2 diabetes mellitus

•PARSABIV, ETELCALCETIDE, To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis

• Prevymis (letermovir) for prevention of an infection called cytomegalovirus (CMV) in patients who are receiving a bone marrow transplant. CMV disease can cause serious health issues in these patients;

• Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly referred to as Lou Gehrig’s disease, a rare disease that attacks and kills the nerve cells that control voluntary muscles;

• RHOPRESSA, NETARSUDIL, To treat glaucoma or ocular hypertension

• Rydapt (midostaurin) to treat adults newly diagnosed with a form of blood cancer known as acute myeloid leukemia who have a specific genetic mutation called FLT3, in combination with chemotherapy;

• Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis, a chronic disorder in which the body’s immune system sends out faulty signals that speed growth of skin cells that then accumulate, causing red, flaky patches that can appear anywhere on the body;

•SOLOSEC, SECNIDAZOLE To treat bacterial vaginosis

• STEGLATRO ERTUGLIFLOZIN To improve glycemic control in adults with type 2 diabetes mellitus

• Symproic (Naldemedine) for the treatment of opioid-induced constipation in adults with chronic noncancer pain; • Tremfya (guselkumab) for the treatment of adults with moderate-to-severe plaque psoriasis;

• Trulance (plecanatide) to treat adults with chronic idiopathic constipation, which is a persistent condition of constipation due to unknown origin;

• TYMLOS, Abaloparatide, To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies

• Vabomere (vaborbactam and meropenem) for treatment of adults with complicated urinary tract infections, including pyelonephritis (kidney infection) caused by bacteria;

• Verzenio (abemaciclib) to treat adults who have hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy);

• Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis;

• VYZULTA LATANOPROSTENE To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

• Xadago (safinamide) as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes;

• XERMELO, TELOTRISTAT ETHYL combined with somatostatin analog (SSA) therapy to treat adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled, and;

• XEPI OZENOXACIN TO TREAT IMPETIGO

•XERMELO, TELOTRISTAT ETHYL, To treat carcinoid syndrome diarrhea

• Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy

USFDA

Advancing Health Through Innovation: 2017 New Drug Therapy Approvals Report (PDF – 2.8MB)

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date
46.	Giapreza	angiotensin II	12/21/2017 Press Release Drug Trials Snapshot	To increase blood pressure in adults with septic or other distributive shock
45.	Macrilen	macimorelin acetate	12/20/2017 Drug Trials Snapshot	For the diagnosis of adult growth hormone deficiency
44.	Steglatro	ertugliflozin	12/19/2017 Drug Trials Snapshot	To improve glycemic control in adults with type 2 diabetes mellitus
43.	Rhopressa	netarsudil	12/18/2017 Drug Trials Snapshot	To treat glaucoma or ocular hypertension
42.	Xepi	ozenoxacin	12/11/2017	To treat impetigo Drug Trials Snapshot
41.	Ozempic	semaglutide	12/5/2017 Drug Trials Snapshot	To improve glycemic control in adults with type 2 diabetes mellitus
40.	Hemlibra	emicizumab	11/16/2017 Press Release Drug Trials Snapshot	To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
39.	Mepsevii	vestronidase alfa-vjbk	11/15/2017 Press Release Drug Trials Snapshot	To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome.
38.	Fasenra	benralizumab	11/14/2017	For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype Drug Trials Snapshot
37.	Prevymis	letermovir	11/8/2017	To prevent infection after bone marrow transplant Drug Trials Snapshot
36.	Vyzulta	latanoprostene bunod ophthalmic solution	11/2/2017	To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Drug Trials Snapshot
35.	Calquence	acalabrutinib	10/31/2017	To treat adults with mantle cell lymphoma Press Release Drug Trials Snapshot
34.	Verzenio	abemaciclib	9/28/2017	To treat certain advanced or metastatic breast cancers Press Release Drug Trials Snapshot
33.	Solosec	secnidazole	9/15/2017	To treat bacterial vaginosis Drug Trials Snapshot
32.	Aliqopa	copanlisib	9/14/2017	To treat adults with relapsed follicular lymphoma Press Release Drug Trials Snapshot
31.	benznidazole	benznidazole	8/29/2017	To treat children ages 2 to 12 years old with Chagas disease Press Release Drug Trials Snapshot
30.	Vabomere	meropenem and vaborbactam	8/29/2017	To treat adults with complicated urinary tract infections Press Release Drug Trials Snapshot
29.	Besponsa	inotuzumab ozogamicin	8/17/2017	To treat adults with relapsed or refractory acute lymphoblastic leukemia Press Release Drug Trials Snapshot
28.	Mavyret	glecaprevir and pibrentasvir	8/3/2017	To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot
27.	Idhifa	enasidenib	8/1/2017	To treat relapsed or refractory acute myeloid leukemia Press Release Drug Trials Snapshot
26.	Vosevi	sofosbuvir, velpatasvir and voxilaprevir	7/18/2017	To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot
25.	Nerlynx	neratinib maleate	7/17/2017	To reduce the risk of breast cancer returning Press Release Drug Trials Snapshot
24.	Tremfya	guselkumab	7/13/2017	For the treatment of adult patients with moderate-to-severe plaque psoriasis Drug Trials Snapshot
23.	Bevyxxa	betrixaban	6/23/2017	For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness Drug Trials Snapshot
22.	Baxdela	delafloxacin	6/19/2017	To treat patients with acute bacterial skin infections Drug Trials Snapshot
21.	Kevzara	sarilumab	5/22/2017	To treat adult rheumatoid arthritis Drug Trials Snapshot
20.	Radicava	edaravone	5/5/2017	To treat patients with amyotrophic lateral sclerosis (ALS) Press Release Drug Trials Snapshot
19.	Imfinzi	durvalumab	5/1/2017	To treat patients with locally advanced or metastatic urothelial carcinoma Web Post Drug Trials Snapshot
18.	Tymlos	abaloparatide	4/28/2017	To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies Drug Trials Snapshot
17.	Rydapt	midostaurin	4/28/2017	To treat acute myeloid leukemia Press Release Chemistry Review(s) (PDF) Drug Trials Snapshot
16.	Alunbrig	brigatinib	4/28/2017	To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Drug Trials Snapshot
15.	Brineura	cerliponase alfa	4/27/2017	To treat a specific form of Batten disease Press Release Drug Trials Snapshot
14.	Ingrezza	valbenazine	4/11/2017	To treat adults with tardive dyskinesia Press Release Chemistry Review(s) (PDF)Drug Trials Snapshot
13.	Austedo	deutetrabenazine	4/3/2017	For the treatment of chorea associated with Huntington’s disease Drug Trials Snapshot, Chemistry Review(s) (PDF)
12.	Ocrevus	ocrelizumab	3/28/2017	To treat patients with relapsing and primary progressive forms of multiple sclerosis Press Release Drug Trials Snapshot
11.	Dupixent	dupilumab	3/28/2017	To treat adults with moderate-to-severe eczema (atopic dermatitis) Press Release Drug Trials Snapshot
10.	Zejula	niraparib	3/27/2017	For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers Press Release Drug Trials Snapshot
9.	Symproic	naldemedine	3/23/2017	For the treatment of opioid-induced constipation Drug Trials Snapshot
8.	Bavencio	avelumab	3/23/2017	To treat metastatic Merkel cell carcinoma Press Release Drug Trials Snapshot
7.	Xadago	safinamide	3/21/2017	To treat Parkinson’s disease Press Release Drug Trials Snapshot Chemistry Review(s) (PDF)
6.	Kisqali	ribociclib	3/13/2017	To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot
5.	Xermelo	telotristat ethyl	2/28/2017	To treat carcinoid syndrome diarrhea Press Release Drug Trials Snapshot
4.	Siliq	brodalumab	2/15/2017	To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot
3.	Emflaza	deflazacort	2/9/2017	To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD) Press Release Drug Trials Snapshot
2.	Parsabiv	etelcalcetide	2/7/2017	To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis Drug Trials Snapshot
1.	Trulance	plecanatide	1/19/2017	To treat Chronic Idiopathic Constipation (CIC) in adult patients. Press Release Drug Trials Snapshot

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA). For instance, new information may become available which could lead to a reconsideration of the original designation or status. If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

USFDA 2017
2017/12/21	Angiotensin II	Giapreza	La Jolla Pharmaceutical
2017/12/20	Ertugliflozin	Steglatro	Merck Sharp Dohme
2017/12/20	Macimorelin acetate	Macrilen	Aeterna Zentaris GmbH
2017/12/18	Netarsudil mesylate	Rhopressa	Aerie Pharmaceuticals
2017/12/11	Ozenoxacin	Xepi	Ferrer Internacional S.A.
2017/12/5	Semaglutide	Ozempic	Novo Nordisk Inc
2017/11/16	Emicizumab	Hemlibra	Genentech	BLA
2017/11/15	Vestronidase alfa	Mepsevii	Ultragenyx Pharmaceutical	BLA
2017/11/14	Benralizumab	Fasenra	AstraZeneca AB	BLA
2017/11/8	Letermovir	Prevymis	Merck Sharp Dohme
2017/11/2	Latanoprostene bunod	Vyzulta	Bausch & Lomb Incorporated
2017/10/31	Acalabrutinib	Calquence	AstraZeneca Pharmaceuticals LP
2017/9/28	Abemaciclib	Verzenio	Eli Lilly
2017/9/15	Secnidazole	Solosec	Symbiomix Therapeutics
2017/9/14	Copanlisib	Aliqopa	Bayer Healthcare Pharmaceuticals
2017/8/29	Benznidazole		Chemo Research
2017/8/29	Meropenem – Vaborbactam	Vabomere	Rempex Pharmaceuticals
2017/8/17	Inotuzumab ozogamicin	Besponsa	Wyeth Pharmaceuticals	BLA
2017/8/3	Glecaprevir – Pibrentasvir	Mavyret	AbbVie
2017/8/1	Enasidenib	Idhifa	Celgene Corporation
2017/7/18	Sofosbuvir – Velpatasvir – Voxilaprevir	Vosevi	Gilead Sciences
2017/7/17	Neratinib maleate	Nerlynx	Puma Biotechnology
2017/7/13	Guselkumab	Tremfya	Janssen Biotech	BLA
2017/6/23	Betrixaban	Bevyxxa	Portola Pharmaceuticals
2017/6/19	Delafloxacin meglumine	Baxdela	Melinta Therapeutics
2017/5/22	Sarilumab	Kevzara	Sanofi Synthelabo	BLA
2017/5/5	Edaravone	Radicava	Mitsubishi Tanabe Pharma America
2017/5/1	Durvalumab	Imfinzi	AstraZeneca UK	BLA
2017/4/28	Abaloparatide	Tymlos	Radius Health
2017/4/28	Midostaurin	Rydapt	Novartis Pharmaceuticals
2017/4/28	Brigatinib	Alunbrig	Ariad Pharmaceuticals
2017/4/27	Cerliponase alfa	Brineura	BioMarin Pharmaceutical	BLA
2017/4/11	Valbenazine	Ingrezza	Neurocrine Biosciences
2017/4/3	Deutetrabenazine	Austedo	Teva Pharmaceuticals
2017/3/28	Ocrelizumab	Ocrevus	Genentech	BLA
2017/3/28	Dupilumab	Dupixent	Regeneron Pharmaceuticals	BLA
2017/3/27	Niraparib	Zejula	Tesaro
2017/3/23	Naldemedine tosylate	Symproic	Shionogi
2017/3/23	Avelumab	Bavencio	EMD Serono	BLA
2017/3/23	Safinamide mesylate	Xadago	Newron Pharmaceuticals
2017/3/21	Ribociclib	Kisqali	Novartis Pharmaceuticals
2017/2/28	Telotristat ethyl	Xermelo	Lexicon Pharmaceuticals
2017/2/15	Brodalumab	Siliq	Valeant Pharmaceuticals	BLA
2017/2/9	Deflazacort	Emflaza	Marathon Pharmaceuticals
2017/2/8	Etelcalcetide hydrochloride	Parsavib	KAI Pharmaceuticals
2017/1/19	Plecanatide	Trulance	Synergy Pharmaceuticals

1 Abaloparatide

RADIUS

str1

Tymlos

FDA 4/28/2017

To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies
Drug Trials Snapshot

Image result for Abaloparatide

link……..https://newdrugapprovals.org/2018/02/13/abaloparatide-%D0%B0%D0%B1%D0%B0%D0%BB%D0%BE%D0%BF%D0%B0%D1%80%D0%B0%D1%82%D0%B8%D0%B4-%D8%A3%D8%A8%D8%A7%D9%84%D9%88%D8%A8%D8%A7%D8%B1%D8%A7%D8%AA%D9%8A%D8%AF-%E5%B7%B4%E7%BD%97%E6%97%81/

2 Abemaciclib

ELI LILLY

Verzenio	abemaciclib	FDA 9/28/2017	To treat certain advanced or metastatic breast cancers Press Release Drug Trials Snapshot

LINK https://newdrugapprovals.org/2015/10/19/abemaciclib-bemaciclib/

3 Acalabrutinib

Calquence		FDA APPROVED 10/31/2017	To treat adults with mantle cell lymphoma Press Release Drug Trials Snapshot

Image result for Acalabrutinib

LINK……….https://newdrugapprovals.org/2018/02/02/acalabrutinib-acp-196-%D0%B0%D0%BA%D0%B0%D0%BB%D0%B0%D0%B1%D1%80%D1%83%D1%82%D0%B8%D0%BD%D0%B8%D0%B1-%D8%A3%D9%83%D8%A7%D9%84%D8%A7%D8%A8%D8%B1%D9%88%D8%AA%D9%8A%D9%86%D9%8A%D8%A8-%E9%98%BF/

4 Angiotensin II

LA JOLLA

Giapreza	angiotensin II	12/21/2017	To increase blood pressure in adults with septic or other distributive shock Press Release Drug Trials Snapshot

Image result for angiotensin II Image result for GIAPREZA

LINK https://newdrugapprovals.org/2017/12/22/fda-approves-drug-giapreza-angiotensin-ii-to-treat-dangerously-low-blood-pressure/

5 AVELUMAB

MERCK

Image result for AVELUMAB

Bavencio		FDA 3/23/2017	To treat metastatic Merkel cell carcinoma Press Release Drug Trials Snapshot

LINK…..https://newdrugapprovals.org/2017/03/24/fda-approves-first-treatment-bavencio-avelumabfor-rare-form-of-skin-cancer/

6 BENRALIZUMAB

ASTRA ZENECA

Fasenra benralizumab

FDA 11/14/2017

For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
Drug Trials Snapshot

Image result for BENRALIZUMAB

7 Benznidazole

CHEMO RESEARCH

Image result for BENZNIDAZOLE

benznidazole		FDA 8/29/2017	To treat children ages 2 to 12 years old with Chagas disease Press Release Drug Trials Snapshot

LINK…https://newdrugapprovals.org/2017/08/30/fda-approves-first-u-s-treatment-benznidazole-for-chagas-disease/

8 BETRIXABAN

PORTOLA PHARMA

Image result for betrixaban

Bevyxxa		FDA 6/23/2017	For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness Drug Trials Snapshot Chemistry Review(s) (PDF)

Image result for betrixaban

LINK…….https://newdrugapprovals.org/2013/03/05/phase-3-portola-pharma-betrixaban-long-acting-oral-direct-factor-xa-inhibitor/

9 BRIGATINIB

Figure imgf000127_0001

TAKEDA

Image result for BRIGATINIB

Alunbrig		FDA 4/28/2017	To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Drug Trials Snapshot

LINK..https://newdrugapprovals.org/2017/01/20/brigatinib-%D0%B1%D1%80%D0%B8%D0%B3%D0%B0%D1%82%D0%B8%D0%BD%D0%B8%D0%B1-%D8%A8%D8%B1%D9%8A%D8%BA%D8%A7%D8%AA%D9%8A%D9%86%D9%8A%D8%A8-%E5%B8%83%E6%A0%BC%E6%9B%BF%E5%B0%BC/

10 BRODALUMAB

VALEANT PHARMA

Siliq		FDA 2/15/2017	To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot

Image result for BRODALUMAB

LINK ,,,,https://newdrugapprovals.org/2017/02/16/fda-approves-new-psoriasis-drug-siliq-brodalumab/

11 CERLIPONASE ALFA

Image result Image result for cerliponase alfa

Brineura		FDA 4/27/2017	To treat a specific form of Batten disease Press Release Drug Trials Snapshot

LINK….https://newdrugapprovals.org/2017/04/28/fda-approves-first-treatment-for-a-form-of-batten-disease-brineura-cerliponase-alfa/

12 Copanlisib

Aliqopa		FDA APPROVED 9/14/2017	To treat adults with relapsed follicular lymphoma Press Release Drug Trials Snapshot

Copanlisib dihydrochloride.png

Image result for copanlisib

LINK…..https://newdrugapprovals.org/2017/11/20/copanlisib/

13 DEFLAZACORT

MARATHON PHARMA

Image result for deflazacort

Emflaza		FDA 2/9/2017	To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD) Press Release Drug Trials Snapshot

LINK……https://newdrugapprovals.org/2017/02/17/deflazacort/

14 DELAFLOXACIN

Baxdela		FDA APPROVED 6/19/2017	To treat patients with acute bacterial skin infections

Image result for delafloxacin

LINK……..https://newdrugapprovals.org/2018/01/25/delafloxacin/

15 Deutetrabenazine

TEVA

Image result for deutetrabenazine

LINK……………https://newdrugapprovals.org/2015/08/15/sd-809-deutetrabenazine-nda-submitted-by-teva/

Austedo		FDA 4/3/2017	For the treatment of chorea associated with Huntington’s disease Drug Trials Snapshot Chemistry Review(s) (PDF)

16 DUPILUMAB

SANOFI/REGENERON

Image result for DUPILUMAB

Dupixent	FDA	3/28/2017	To treat adults with moderate-to-severe eczema (atopic dermatitis) Press Release Drug Trials Snapshot

LINK…….https://newdrugapprovals.org/2017/03/29/fda-approves-new-eczema-drug-dupixent-dupilumab/

17 DURVALUMAB

ASTRA ZENECA

Image result for DURVALUMAB

Imfinzi

durvalumab FDA 5/1/2017To treat patients with locally advanced or metastatic urothelial carcinoma
Web Post
Drug Trials Snapshot

18 EDAVARONE

MITSUBISHI TANABE

Radicava		FDA 5/5/2017	To treat patients with amyotrophic lateral sclerosis (ALS) Press Release Drug Trials Snapshot

Image result for EDARAVONE

LINK………https://newdrugapprovals.org/2017/05/06/fda-approves-drug-to-treat-als-radicava-edaravone-%D1%8D%D0%B4%D0%B0%D1%80%D0%B0%D0%B2%D0%BE%D0%BD-%D8%A5%D9%8A%D8%AF%D8%A7%D8%B1%D8%A7%D9%81%D9%88%D9%86-%E4%BE%9D%E8%BE%BE%E6%8B%89%E5%A5%89/

19 EMICIZUMAB

ROCHE

Image result for EMICIZUMAB

Hemlibra	emicizumab	FDA 11/16/2017	To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. Press Release Drug Trials Snapshot

LINK https://newdrugapprovals.org/2017/11/17/fda-approves-new-treatment-hemlibra-emicizumab-kxwh-to-prevent-bleeding-in-certain-patients-with-hemophilia-a/

Image result for EMICIZUMAB

20 Enasidenib

Image result for Enasidenib

Idhifa		FDA 8/1/2017	To treat relapsed or refractory acute myeloid leukemia Press Release Drug Trials Snapshot

LINK……https://newdrugapprovals.org/2017/08/02/enasidenib-%D1%8D%D0%BD%D0%B0%D1%81%D0%B8%D0%B4%D0%B5%D0%BD%D0%B8%D0%B1-%D8%A5%D9%8A%D9%86%D8%A7%D8%B3%D9%8A%D8%AF%D9%8A%D9%86%D9%8A%D8%A8-%E4%BC%8A%E9%82%A3%E5%B0%BC%E5%B8%83/

21 Ertugliflozin

MERCK

Image result for ERTUGLIFLOZIN

Steglatro	ertugliflozin	FDA 12/19/2017	To improve glycemic control in adults with type 2 diabetes mellitus Drug Trials Snapshot

LINK https://newdrugapprovals.org/2014/02/10/ertugliflozin/

Image result for ERTUGLIFLOZIN

22 ETELCALCETIDE

Amgen

Parsabiv		FDA APPROVED 2/7/2017	To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis Drug Trials SnapshotSYNTHESIS LINK……..https://cen.acs.org/articles/96/i4/the-year-in-new-drugs-2018.html

SYNTHESIS LINK……..https://cen.acs.org/articles/96/i4/the-year-in-new-drugs-2018.html

23 GLECAPREVIR

ABBVIE

Mavyret	glecaprevir and pibrentasvir	FDA 8/3/2017	To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot

LINK https://newdrugapprovals.org/2016/10/05/glecaprevir-abt-493/

24 GUSELKUMAB

JOHNSON AND JOHNSON

Tremfya

guselkumab

FDA 7/13/2017

For the treatment of adult patients with moderate-to-severe plaque psoriasis
Drug Trials Snapshot

Image result for GUSELKUMAB

25 Inotuzumab ozogamicin

PFIZER

Image result for inotuzumab ozogamicin

Besponsa		FDA 8/17/2017	To treat adults with relapsed or refractory acute lymphoblastic leukemia Press Release Drug Trials Snapshot

LINK….https://newdrugapprovals.org/2015/10/23/fda-grants-breakthrough-status-for-pfizers-leukaemia-drug-inotuzumab-ozogamicin/

26 LATANOPROSTENE

VALEANT

Image result for LATANOPROSTENE

latanoprostene bunod ophthalmic solution

FDA 11/2/2017

To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Drug Trials Snapshot

LINK https://newdrugapprovals.org/2014/09/27/nicox-stock-leaps-on-positive-ph-iii-glaucoma-drug-data-%E8%8B%B1%E6%96%87%E5%90%8D%E7%A7%B0/

27 LETERMOVIR

MERCK

Image result for LETERMOVIR

Prevymis		FDA 11/8/2017	To prevent infection after bone marrow transplant Drug Trials Snapshot

LINK https://newdrugapprovals.org/2016/05/16/letermovir-aic-246/

28 Macimorelin acetate

AETERNA ZENTARIS

Macrilen	macimorelin acetate	FDA 12/20/2017	For the diagnosis of adult growth hormone deficiency Drug Trials Snapshot

LINK https://newdrugapprovals.org/2014/01/07/aeterna-zentaris-submits-new-drug-application-to-fda-for-macimorelin-acetate-aezs-130-for-evaluation-of-aghd-2/

29 MEROPENEM

Image result for MEROPENEM

30 MIDOSTAURIN

NOVARTIS

Chemistry Review(s) (PDF)

Image result for MIDOSTAURIN

Rydapt		FDA 4/28/2017	To treat acute myeloid leukemia Press Release Drug Trials Snapshot

LINK…….https://newdrugapprovals.org/2017/04/29/fda-approves-new-combination-treatment-for-acute-myeloid-leukemia-rydapt-midostaurin/

31 Naldemedine

FDA 3/23/2017, Symproic, For the treatment of opioid-induced constipation

Image result for naldemedine

LINK……..https://newdrugapprovals.org/2018/01/24/naldemedine-%E3%83%8A%E3%83%AB%E3%83%87%E3%83%A1%E3%82%B8%E3%83%B3%E3%83%88%E3%82%B7%E3%83%AB%E9%85%B8%E5%A1%A9/

32 NERATINIB MALEATE

PUMA BIOTECH

Image result for NERATINIB

Nerlynx	FDA	7/17/2017	To reduce the risk of breast cancer returning Press Release Drug Trials Snapshot

LINK…https://newdrugapprovals.org/2014/04/11/neratinib-hki-272-puma-presents-positive-results-from-phase-ii-trial-of-its-investigational-drug-pb272/

33 NETARSUDIL

Rhopressa		FDA APPROVED 12/18/2017	To treat glaucoma or ocular hypertension

Image result for Netarsudil

LINK……https://newdrugapprovals.org/2018/01/29/netarsudil/

34 NIRAPARIB

TESARO

Zejula	FDA	3/27/2017	For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers Press Release Drug Trials Snapshot

Figure imgf000023_0001

LINK…https://newdrugapprovals.org/2016/12/22/niraparib-mk-4827/

35 OCRELIZUMAB

ROCHE

Ocrevus	FDA	3/28/2017	To treat patients with relapsing and primary progressive forms of multiple sclerosis Press Release Drug Trials Snapshot

Image result for ocrelizumab

LINK..https://newdrugapprovals.org/2017/03/30/fda-approves-new-drug-to-treat-multiple-sclerosis-ocrevus-ocrelizumab/

36 OZENOXACIN

MEDIMETRIX

Image result for ozenoxacin

LINK https://newdrugapprovals.org/2014/03/28/ozenoxacin-in-phase-3-topical-formulation-in-the-treatment-of-impetigo/

Image result for ozenoxacin

Xepi	ozenoxacin	FDA 12/11/2017	To treat impetigo Drug Trials Snapshot

37 Pibrentasvir

ABBVIE

Mavyret	glecaprevir and pibrentasvir	FDA 8/3/2017	To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot

LINK https://newdrugapprovals.org/2016/06/08/abt-530-pibrentasvir/

38 PLECANATIDE

Plecanatide 普卡那肽 ليكاناتيد плеканатид

SYNERGY PHARMA

Image result for PLECANATIDE

Trulance		FDA APPROVED 1/19/2017	To treat Chronic Idiopathic Constipation (CIC) in adult patients. Press Release Drug Trials Snapshot

LINK ….https://newdrugapprovals.org/2016/04/21/plecanatide-%E6%99%AE%E5%8D%A1%E9%82%A3%E8%82%BD-%D9%84%D9%8A%D9%83%D8%A7%D9%86%D8%A7%D8%AA%D9%8A%D8%AF-%D0%BF%D0%BB%D0%B5%D0%BA%D0%B0%D0%BD%D0%B0%D1%82%D0%B8%D0%B4/

39 RIBOCICLIB

NOVARTIS

2D chemical structure of 1374639-75-4

Structure..link for correct structure

Kisqali		FDA 3/13/2017	To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot

Image result for RIBOCICLIB

LINK https://newdrugapprovals.org/2015/10/19/ribociclib/

40 SARILUMAB

SANOFI /REGENERON

Kevzara	sarilumab	FDA 5/22/2017	To treat adult rheumatoid arthritis Drug Trials Snapshot

LINK https://newdrugapprovals.org/2013/11/25/late-stage-success-for-sanofiregeneron-ra-drug-sarilumab/

Image result for SARILUMAB

41 SECNIDAZOLE

SYMBIOMIX

Solosec	FDA	9/15/2017	To treat bacterial vaginosis Drug Trials Snapshot

Image result for SECNIDAZOLE

link….https://newdrugapprovals.org/2017/11/03/secnidazole-%D1%81%D0%B5%D0%BA%D0%BD%D0%B8%D0%B4%D0%B0%D0%B7%D0%BE%D0%BB-%D8%B3%D9%8A%D9%83%D9%86%D9%8A%D8%AF%D8%A7%D8%B2%D9%88%D9%84-%E5%A1%9E%E5%85%8B%E7%A1%9D%E5%94%91/

42 SAFINAMIDE

NEWRON PHARMA

Image result for safinamide

Chemistry Review(s) (PDF) for correct structure

Xadago		FDA 3/21/2017	To treat Parkinson’s disease Press Release Drug Trials Snapshot

LINK…https://newdrugapprovals.org/2017/03/22/fda-approves-drug-xadago-safinamide-%D1%81%D0%B0%D1%84%D0%B8%D0%BD%D0%B0%D0%BC%D0%B8%D0%B4-%D8%B3%D8%A7%D9%81%D9%8A%D9%86%D8%A7%D9%85%D9%8A%D8%AF-%E6%B2%99%E9%9D%9E%E8%83%BA-to-treat-parkins/

43 Semaglutide

NOVO NORDISK

Image result for SEMAGLUTIDE

Ozempic	semaglutide	FDA 12/5/2017	To improve glycemic control in adults with type 2 diabetes mellitus Drug Trials Snapshot

LINK https://newdrugapprovals.org/2013/07/22/a-survey-of-promising-late-stage-diabetes-drugs/

Image result for SEMAGLUTIDE

44 SOFOSBUVIR

LINK https://newdrugapprovals.org/2013/12/11/us-approves-breakthrough-hepatitis-c-drug-sofosbuvir-all-about-drugs/

45 TELOTRISTAT ETHYL

LEXICON

LX1606 Hippurate.png

Xermelo		FDA 2/28/2017	To treat carcinoid syndrome diarrhea Press Release Drug Trials Snapshot

Image result for Lexicon Pharmaceuticals, Inc. STR1

46 VABORBACTAM

THE MEDICINES CO

Vabomere	meropenem and vaborbactam	FDA 8/29/2017	To treat adults with complicated urinary tract infections Press Release Drug Trials Snapshot

Image result for VABOMERE

LINK https://newdrugapprovals.org/2017/09/05/vaborbactam-%D0%B2%D0%B0%D0%B1%D0%BE%D1%80%D0%B1%D0%B0%D0%BA%D1%82%D0%B0%D0%BC-%D9%81%D8%A7%D8%A8%D9%88%D8%B1%D8%A8%D8%A7%D9%83%D8%AA%D8%A7%D9%85-%E6%B3%95%E7%A1%BC%E5%B7%B4%E5%9D%A6/

47 VALBENAZINE

NEUROCRINE

Image result for valbenazine

Chemistry Review(s) (PDF)

Image result for VALBENAZINE

Ingrezza		FDA 4/11/2017	To treat adults with tardive dyskinesia Press Release Drug Trials Snapshot

LINK…………..https://newdrugapprovals.org/2017/04/12/fda-approves-first-drug-ingrezza-valbenazine-to-treat-tardive-dyskinesia/

48 Vestronidase alfa-vjbk

ULTRAGENYX

Mepsevii	vestronidase alfa-vjbk	FDA 11/15/2017	To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. Press Release Drug Trials Snapshot

Image result for vestronidase alfa-vjbk

LINK…https://newdrugapprovals.org/2017/11/16/fda-approves-mepsevii-vestronidase-alfa-vjbk-for-treatment-for-rare-genetic-enzyme-disorder/

49 VELPATASVIR

LINK https://newdrugapprovals.org/2016/07/30/velpatasvir-gs-5816-gilead-sciences-%D0%B2%D0%B5%D0%BB%D0%BF%D0%B0%D1%82%D0%B0%D1%81%D0%B2%D0%B8%D1%80-%D9%81%D8%A7%D9%84%D8%A8%D8%A7%D8%AA%D8%A7%D8%B3%D9%81%D9%8A%D8%B1-%E7%BB%B4%E5%B8%95/

50 VOXILAPREVIR

GILEAD

Image result for VOXILAPREVIR

Vosevi	sofosbuvir, velpatasvir and voxilaprevir	FDA 7/18/2017	To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot

LINK https://newdrugapprovals.org/2017/07/19/voxilaprevir-%D9%81%D9%88%D9%83%D8%B3%D9%8A%D9%84%D8%A7%D8%A8%D8%B1%D9%8A%D9%81%D9%8A%D8%B1-%E4%BC%8F%E8%A5%BF%E7%91%9E%E9%9F%A6-%D0%B2%D0%BE%D0%BA%D1%81%D0%B8%D0%BB%D0%B0%D0%BF%D1%80%D0%B5%D0%B2/

SECTION B; EMA approvals

European Medicines Agency’s – Human medicines: Highlights of 2017

Advances in medicines authorizations are essential for public health as they have the potential to improve treatment of diseases. In 2017, EMA recommended 92 medicines for marketing authorization. Of these, 35 had a new active substance, which has never been authorized in the European Union (EU) before. Many of these medicines represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advanced therapies42. Amongst the 35 new active substances (NAS) that EMA recommended, 11 were new drugs and biologics to treat cancer, 05 to treat neurological disorders, 04 for infectious diseases, 04 for immunology/rheumatology, 03 for endocrinology, 02 each for Uro-nephrology, haematology, and dermatology, 01 for Pneumonology, and 01 for hepatology/gastroenterology class of drugs.

EUROPE

2017/11/16	Niraparib	Zejula	Tesaro UK Limited	O	NME
2017/11/10	Adalimumab	Cyltezo	Boehringer Ingelheim International GmbH	B
2017/11/10	Miglustat	Miglustat Gen.Orph	Gen.Orph	G
2017/11/10	Ritonavir	Ritonavir Mylan	MYLAN S.A.S	G
2017/11/10	Padeliporfin	Tookad	STEBA Biotech S.A
2017/11/10	Guselkumab	Tremfya	Janssen-Cilag International N.V.		BLA
2017/9/27	Dupilumab	Dupixent	sanofi-aventis groupe		BLA
2017/9/21	Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide	Symtuza	Janssen-Cilag International N.V.
2017/9/21	Atezolizumab	Tecentriq	Roche Registration Limited		BLA
2017/9/18	Avelumab	Bavencio	Merck Serono Europe Limited	O	BLA
2017/9/18	Entecavir	Entecavir Mylan	Mylan S.A.S	G
2017/9/18	Lacosamide	Lacosamide Accord	Accord Healthcare Ltd	G
2017/9/18	Midostaurin	Rydapt	Novartis Europharm Ltd	O	NME
2017/9/18	Telotristat ethyl	Xermelo	Ipsen Pharma	O	NME
2017/9/5	Trientine	Cuprior	GMP-Orphan SA
2017/9/5	Efavirenz / Emtricitabine / Tenofovir disoproxil	Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan	Mylan S.A.S	G
2017/8/24	Tivozanib hydrochloride monohydrate	Fotivda	EUSA Pharma (UK) Limited		NME
2017/8/24	Adalimumab	Imraldi	Samsung Bioepis UK Limited (SBUK)	B
2017/8/24	Nitisinone	Nitisinone MDK (previously Nitisinone MendeliKABS)	MendeliKABS Europe Ltd	G
2017/8/22	Ribociclib	Kisqali	Novartis Europharm Ltd		NME
2017/8/22	Cladribine	Mavenclad	Merck Serono Europe Limited
2017/7/26	Glecaprevir / Pibrentasvir	Maviret	AbbVie Limited		NME
2017/7/26	Sofosbuvir / Velpatasvir / Voxilaprevi	Vosevi	Gilead Sciences International Ltd		NME
2017/7/19	Insulin lispro	Insulin lispro Sanofi	sanofi-aventis groupe	B
2017/7/19	Patiromer sorbitex calcium	Veltassa	Vifor Fresenius Medical Care Renal Pharma France		NME
2017/7/17	Efavirenz / Emtricitabine / Tenofovir disoproxil	Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva	Zentiva k.s.	G
2017/7/17	Brodalumab	Kyntheum	LEO Pharma A/S		BLA
2017/7/17	beclometasone / formoterol / glycopyrronium bromide	Trimbow	Chiesi Farmaceutici S.p.A.
2017/7/13	Rituximab	Blitzima	Celltrion Healthcare Hungary Kft.	B
2017/7/13	Cariprazine	Reagila	Gedeon Richter
2017/7/10	Spheroids of human autologous matrix-associated chondrocytes	Spherox	CO.DON AG
2017/7/6	Cenegermin	Oxervate	Dompe farmaceutici s.p.a.	O	BLA
2017/6/29	Inotuzumab ozogamicin	Besponsa	Pfizer Limited	O	BLA
2017/6/23	Etanercept	Erelzi	Sandoz GmbH
2017/6/23	Sarilumab	Kevzara	Sanofi-Aventis Groupe		NME
2017/6/23	Dimethyl fumarate	Skilarence	Almirall S.A
2017/6/23	Carglumic acid	Ucedane	Lucane Pharma	G
2017/6/15	Rituximab	Rixathon, Riximyo B	Sandoz GmbH
2017/6/2	Pentosan polysulfate sodium	Elmiron	bene-Arzneimittel GmbH
2017/6/2	Nonacog beta pegol	Refixia	Novo Nordisk A/S		BLA
2017/5/30	Cerliponase alfa	Brineura	BioMarin International Limited	O E	BLA
2017/5/30	Nusinersen	Spinraza	Biogen Idec Ltd	O	NME
2017/5/24	Meningococcal group b vaccine (recombinant, adsorbed)	Trumenba	Pfizer Limited
2017/5/22	Ivabradine	Ivabradine Accord	Accord Healthcare Ltd	G
2017/5/8	Dinutuximab beta	Dinutuximab beta Apeiron	Apeiron Biologics AG	O E
2017/4/28	Emtricitabine – tenofovir disoproxil mixt	Emtricitabine/Tenofovir disoproxil Krka d.d.	KRKA, d.d., Novo mesto	G
2017/4/24	Parathyroid hormone	Natpar	Shire Pharmaceuticals Ireland Ltd	O C	BLA
2017/4/20	Edoxaban	Roteas	Daiichi Sankyo Europe GmbH
2017/3/22	Tofacitinib citrate	Xeljanz	Pfizer Limited		NME
2017/3/20	Umeclidinium	Rolufta	GlaxoSmithKline Trading Services Limited
2017/3/3	Chlormethine	Ledaga	Actelion Registration Ltd.	O
2017/2/27	Pregabalin	Pregabalin Zentiva	Zentiva k.s.	G
2017/2/17	Rituximab	Truxima	Celltrion Healthcare Hungary Kft.	B
2017/2/13	Etanercept	Lifmior	Pfizer Limited
2017/2/13	Baricitinib	Olumiant	Eli Lilly Nederland B.V.		NME
2017/1/19	Mercaptamine	Cystadrops	Orphan Europe S.A.R.L.	O
2017/1/18	Bezlotoxumab	Zinplava	Merck Sharp & Dohme Limited		NME
2017/1/11	Teriparatide	Movymia	STADA Arzneimittel AG	B
2017/1/11	Insulin glargine / lixisenatide	Suliqua	Sanofi-Aventis Groupe
2017/1/9	Insulin aspart	Fiasp	Novo Nordisk A/S
2017/1/9	Tadalafil	Tadalafil	Mylan S.A.S	G
2017/1/9	Tenofovir alafenamide	Vemlidy	Gilead Sciences International Ltd
2017/1/4	Lonoctocog alfa	Afstyla	CSL Behring GmbH		BLA
2017/1/4	Darunavir	Darunavir Mylan	Mylan S.A.S.	G
2017/1/4	Insulin glargine	Lusduna	Merck Sharp & Dohme Limited	B
2017/1/4	Teriparatide	Terrosa	Gedeon Richter Plc.	B

SECTION B; EMA Approvals

Combined drugs USFDA+EMA +PMDA list are listed below. trying to simplify search

1 Abaloparatide USFDA

2 Abemaciclib USFDA

3 ACALABRUTINIB USFDA

3A ALOFISEL EMA

3B AMENAMEVIR JAPAN

4 ANGIOTENSIN II USFDA

4A Atezolizumab EMA

5 AVELUMAB USFDA+EMA

6 BENRALIZUMAB USFDA+EMA

6A BARICITINIB JAPAN

7 BENZNIDAZOLE USFDA

8 BETRIXABAN USFDA

9 BRIGATINIB USFDA

10 BRODALUMAB USFDA+EMA

10A BUROSUMAB EMA

10B CARIPRAZINE HYDROCHLORIDE EMA

11 CERLIPONASE ALPA USFDA+EMA

12 COPANLISIB USFDA

13 DEFLAZACORT USFDA

14 Delafloxacin USFDA

15 Deutetrabenazine USFDA

16DUPILUMAB USFDA+EMA

17 DURVALUMAB USFDA

18 EDAVARONE USFDA

19 EMICIZUMAB USFDA

20 Enasidenib USFDA

21 ERTUGLIFLOZIN USFDA

22 ETELCALCETIDE USFDA

22A FORODESINE JAPAN

22B FLUCICLOVINE EMA

23 GLECAPREVIR USFDA+EMA

24 GUSELKUMAB USFDA+EMA

25 INOTUZUMAB OZOGAMICIN USFDA+EMA

26 LATANOPROSTENE USFDA

27 LETERMOVIR USFDA+EMA

27A Utetium lu 177 dotatate EMA

28 MACIMORELIN ACETATE USFDA

29 MEROPENEM USFDA

30 MIDOSTAURIN USFDA+EMA

31 NALDEMEDINE USFDA

32 NERATINIB USFDA

33 NETARSUDIL USFDA

34 NIRAPARIB USFDA+EMA

34A NONACOG EMA

34B NUCINERSEN EMA +Japan

35 Ocrelizumab USFDA+EMA

35A OXERVATE EMA

36 OZENOXACIN USFDA

36A PATIROMER EMA

36B PADELIPORFIN EMA

36C PEMAFIBRATE JAPAN

37 PIBRENTASVIR USFDA+EMA

38 PLECANATIDE USFDA

38A PRALATREXATE JAPAN

39 RIBOCICLIB USFDA+EMA

39A ROLAPITANT EMA

39BRURLOCTOCOG EMA

40 SARILUMAB USFDA+EMA

41 SECNIDAZOLE USFDA

42 SAFINAMIDE USFDA

43 SEMAGLUTIDE USFDA+EMA

43A SODIUM ZIRCONIUM CYCLOCYLICATE EMA

44 SOFOSBUVIR USFDA+EMA

44A SPHEROX EMA

45 TELOTRISTAT ETHYL USFDA+EMA

45A TIVOZANIB EMA

45B TOFACITINIB EMA

45C TRUMENBA EMA

46 VABORBACTAM USFDA

47 VALBENAZINE USFDA

48 VESTRONIDASE ALFA-VJBK USFDA

49 VELPATASVIR USFDA+EMA

50 VOXILAPREVIR USFDA+EMA

Drugs EMA list missed out in usfda list

3A ALOFISEL

link………https://newdrugapprovals.org/2018/03/02/alofisel-darvadstrocel-cx-601/

4A Atezolizumab

WILL BE UPDATED

10A BUROSUMAB

WILL BE UPDATED

10B CARIPRAZINE HYDROCHLORIDE

WILL BE UPDATED

22B FLUCICLOVINE

Image result for FLUCICLOVINE

LINK https://newdrugapprovals.org/2016/05/28/fda-approves-new-diagnostic-imaging-agent-fluciclovine-f-18-to-detect-recurrent-prostate-cancer/

SEE EMA

Axumin : EPAR – Summary for the public

EN = English

06/07/2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004197/human_med_002100.jsp&mid=WC0b01ac058001d124

Marketing-authorisation holder	Blue Earth Diagnostics Ltd
Revision	0
Date of issue of marketing authorisation valid throughout the European Union	22/05/2017

Contact address:

Blue Earth Diagnostics Ltd
215 Euston Road
London NW1 2BE
United Kingdom

27A Lutetium lu 177 dotatate

WILL BE UPDATED

34A NONACOG

WILL BE UPDATED

34B NUCINERSEN

EMA AND JAPAN 2017 APPROVED

Image result for Nusinersen sodium

LINK …….https://newdrugapprovals.org/2018/03/14/nusinersen-sodium-%E3%83%8C%E3%82%B7%E3%83%8D%E3%83%AB%E3%82%BB%E3%83%B3%E3%83%8A%E3%83%88%E3%83%AA%E3%82%A6%E3%83%A0/

35A OXERVATE

WILL BE UPDATED

36A PATIROMER

WILL BE UPDATED

36B PADELIPORFIN

NAME	Tookad
AGENCY PRODUCT NUMBER	EMEA/H/C/004182
ACTIVE SUBSTANCE	padeliporfin di-potassium
INTERNATIONAL NON-PROPRIETARY NAME(INN) OR COMMON NAME	padeliporfin
THERAPEUTIC AREA	Prostatic Neoplasms
ANATOMICAL THERAPEUTIC CHEMICAL (ATC) CODE	L01XD07
ADDITIONAL MONITORING	This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

MARKETING-AUTHORISATION HOLDER	STEBA Biotech S.A
REVISION	0
DATE OF ISSUE OF MARKETING AUTHORISATION VALID THROUGHOUT THE EUROPEAN UNION	10/11/2017

Contact address:

STEBA Biotech S.A
7 place du theatre
L-2613 Luxembourg
Luxembourg

Image result for PADELIPORFIN

38A PRALATREXATE

Japan approved 2017

2017/7/3

PMDA

JAPAN

Pralatrexate

Difolta

Mundipharma

NME

LINK https://newdrugapprovals.org/2018/03/16/pralatrexate-%E3%83%97%E3%83%A9%E3%83%A9%E3%83%88%E3%83%AC%E3%82%AD%E3%82%B5%E3%83%BC%E3%83%88/

39A ROLAPITANT

WILL BE UPDATED

39B RURLOCTOCOG

WILL BE UPDATED

43A SODIUM ZIRCONIUM

WILL BE UPDATED

44A SPHEROX

WILL BE UPDATED

45A TIVOZANIB

Image result for TIVOZANIB EMA

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

Treatment of advanced renal cell carcinoma

Fotivda : EPAR -Product Information

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004131/human_med_002146.jsp&mid=WC0b01ac058001d124

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004131/WC500239035.pdf

str6

Tivozanib is synthesized in three main steps using well defined starting materials with acceptable
specifications.
Adequate in-process controls are applied during the synthesis. The specifications and control methods for
intermediate products, starting materials and reagents have been presented. The critical process
parameters are duly justified, methodology is presented and control is adequate.
The characterisation of the active substance and its impurities are in accordance with the EU guideline on
chemistry of new active substances. Potential and actual impurities were well discussed with regards to
their origin and characterised.
The active substance is packaged in a low-density polyethylene (LDPE) bag which complies with the EC
directive 2002/72/EC and EC 10/2011 as amended.

Product details

Name	Fotivda
Agency product number	EMEA/H/C/004131
Active substance	tivozanib
International non-proprietary name(INN) or common name	tivozanib hydrochloride monohydrate
Therapeutic area	Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code	L01XE

Publication details

Marketing-authorisation holder	EUSA Pharma (UK) Limited
Revision	0
Date of issue of marketing authorisation valid throughout the European Union	24/08/2017

Contact address:

EUSA Pharma (UK) Limited
Breakspear Park, Breakspear Way
Hemel Hempstead, HP2 4TZ
United Kingdom

LINK………https://newdrugapprovals.org/2018/02/26/tivozanib-%E3%83%86%E3%82%A3%E3%83%9C%E3%82%B6%E3%83%8B%E3%83%96%E5%A1%A9%E9%85%B8%E5%A1%A9%E6%B0%B4%E5%92%8C%E7%89%A9/

45B TOFACITINIB

WILL BE UPDATED

45C TRUMENBA

WILL BE UPDATED

SECTION C JAPANFORODOS

SECTION C New Drugs JAPAN

https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html

FY 2017 (April – November)

JAPAN 2017

2017/9/27	Avelumab (genetical recombination)	Bavencio	Merck Serono	BLA
2017/9/27	Glecaprevir – pibrentasvir mixt	Maviret	Abbvie	NME
2017/9/27	Daratumumab (genetical recombination)	Darzalex	Janssen Pharmaceutical	BLA
2017/9/27	Belimumab (genetical recombination)	Benlysta	GlaxoSmithKline	BLA
2017/9/27	Bezlotoxumab (genetical recombination)	Zinplava	MDS	BLA
2017/9/27	Palbociclib	Ibrance	Pfizer	NME
2017/9/27	Lonoctocog alfa (genetical recombination)	Afstyla	CSL Behring	BLA
2017/9/27	Rupatadine fumarate	Rupafin	Teikoku seiyaku	NME
2017/9/27	Sarilumab (genetical receombination)	Kevzara	Sanofi	BLA
2017/9/27	Flutemetamol (18F)	Vizamyl	Nihon Medi-Physics	NME
2017/7/3	Nusinersen sodium	Spinraza	Biogen Japan
2017/7/3	Romidepsin	Istodax	Celgene	NME
2017/7/3	Pralatrexate	Difolta	Mundipharma	NME
2017/7/3	Amenamevir	Amenalief	Maruho	NME
2017/7/3	Baricitinib	Olumiant	Lilly	NME
2017/7/3	Pemafibrate	Parmodia	Kowa	NME
2017/3/30	Human prothrombin complex, freeze-dried concentrated	Kcentra	CSL Behring
2017/3/30	Ixazomib citrate	Ninlaro	Takeda	NME
2017/3/30	Forodesine hydrochloride	Mundesine	Mundipharma
2017/3/30	Aflibercept beta (genetical recombination)	Zaltrap	Sanofi
2017/3/30	Hydromorphone hydrochloride	Narusus, Narurapid	DaiichiSankyo-pp
2017/3/30	Naldemedine tosylate	Symproic	Shionogi	NME
2017/3/30	Guanfacine hydrochloride	Intuniv	Shionogi

3B AMENAMEVIR

Originally developed by Astellas, the drug was licensed to Maruho. Amenamevir treats herpes zoster by inhibiting the activity of the helicase-primer enzyme during viral DNA replication and blocking the virus’s proliferation.

Amenalief® is an oral film-coated tablet containing 200 mg of amenamevir per tablet. Recommended dose of 1 day, 400mg each time, after meals.

LINK https://newdrugapprovals.org/2018/03/12/amenamevir-%E3%82%A2%E3%83%A1%E3%83%8A%E3%83%A1%E3%83%93%E3%83%AB/

22A FORODESINE HYDROCHLORIDE

LINK https://newdrugapprovals.org/2018/03/06/forodesine-hydrochloride/

6A BARICITINIB JAPAN

Originally developed by Incyte, Baricitinib was later licensed to and for sale by Lilly under the trade name Olumiant®. Baricitinib is an irreversible inhibitor of Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2). Olumiant® is approved for the treatment of mild to moderate rheumatoid arthritis in adult patients who are not responsive or intolerant to other anti-arthritic drugs. This product can be used alone or in combination with methotrexate.

Olumiant® is a film-coated tablet containing 2 mg or 4 mg per tablet. Recommended oral dose is 4mg daily, with meals or fasting food, you can take any time period.

2017/7/3PMDA Baricitinib Olumiant Lilly

LINK https://newdrugapprovals.org/2013/06/17/lilly-and-partner-incyte-corp-have-presented-more-promising-data-on-their-investigational-jak-inhibitor-baricitinib-for-rheumatoid-arthritis/

36C PEMAFIBRATE

LINK https://newdrugapprovals.org/2016/04/24/pemafibrate/

SECTION D

CDSCO INDIA

http://www.cdsco.nic.in/forms/list.aspx?lid=2034&Id=11 http://www.cdsco.nic.in/forms/list.aspx?lid=2034&Id=11

KEEP WATCHING UNDER CONSTRUCTION AND WILL BE PASTED SOON………………………………………..

REFERENCES

1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/01/news_detail_002886.jsp&mid=WC0b01ac058004d5c1

2 http://www.ema.europa.eu/docs/en_GB/document_library/Report/2018/01/WC500242079.pdf

“NEW DRUG APPROVALS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent

amcrasto@gmail.com

I , Dr A.M.Crasto is writing this blog to share the knowledge/views, after reading Scientific Journals/Articles/News Articles/Wikipedia. My views/comments are based on the results /conclusions by the authors(researchers). I do mention either the link or reference of the article(s) in my blog and hope those interested can read for details. I am briefly summarising the remarks or conclusions of the authors (researchers). If one believe that their intellectual property right /copyright is infringed by any content on this blog, please contact or leave message at below email address amcrasto@gmail.com. It will be removed ASAP

////////EMA APPROVALS, USFDA Approvals, ACALABRUTINIB, AVELUMAB, BETRIXABAN, BRODALUMAB, COPANLISIB, DEFLAZACORT, Delafloxacin, Deutetrabenazine, DUPILUMAB, ETELCALCETIDE, Naldemedine, NETARSUDIL, NIRAPARIB, Ocrelizumab, PLECANATIDE, RIBOCICLIB, SAFINAMIDE, TELOTRISTAT ETHYL, VALBENAZINE, CERLIPONASE, BRIGATINIB, MIDOSTAURIN, Abaloparatide, BENZNIDAZOLE, NERATINIB, inotuzumab ozogamicin, Enasidenib, LETERMOVIR, GLECAPREVIR, PIBRENTASVIR, VOXILAPREVIR, SOFOSBUVIR, EDAVARONE, abemaciclib, ANGIOTENSIN II, VESTRONIDASE, macimorelin acetate, ERTUGLIFLOZIN, SEMAGLUTIDE, EMICIZUMAB, eu 2017, fda 2017, BENRALIZUMAB, DURVALUMAB, GUSELKUMAB, LATANOPROSTENE, OZENOXACIN, SARILUMAB, SECNIDAZOLE, BENRALIZUMAB, TIVOZANIB, SARILUMAB, FLUCICLOVINE,

	DR ANTHONY MELVIN CR… on Lurbinectedin
	DR ANTHONY MELVIN CR… on AZITHROMYCIN, アジスロマイシン;
	DR ANTHONY MELVIN CR… on BAY 1895344
	DR ANTHONY MELVIN CR… on ADAFOSBUVIR, адафосбувир , أدا…
	DR ANTHONY MELVIN CR… on AK 3280

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Product details

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Therapeutic indication

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Modulation of Reactive Oxygen Species Photogeneration of Bacteriopheophorbide a Derivatives by Exocyclic E-Ring Opening and Charge Modifications

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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO, Novel Drug Approvals for 2017, A Review Compilation (USFDA, EMA, PMDA, CDSCO).

Any errors in this compilation, email amcrasto@gmail.com, Call +919323115463

SECTION A; USFDA Approvals

6 BENRALIZUMAB

7 Benznidazole

15 Deutetrabenazine

17 DURVALUMAB

20 Enasidenib

24 GUSELKUMAB

25 Inotuzumab ozogamicin

26 LATANOPROSTENE

28 Macimorelin acetate

32 NERATINIB MALEATE

40 SARILUMAB

41 SECNIDAZOLE

43 Semaglutide