Home » Uncategorized
Category Archives: Uncategorized
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Personal Links
- my sites on the net
- DR ANTHONY MELVIN CRASTO
- GOOGLE GROUP ORGANIC PROCESS DEVELOPMENT
- mixxt
- epernicus
- scipeople
- jimdo
- yolasite
- my cv
- slidestaxx
- wordpress blog
- ABOUT ME
- BRANDSITE
- SKILLPAGES
- Academia.edu
- DIIGO
- WIX
- WIX BLOG
- ISSUU
- SCRIBD
- BIZ
- GOOGLE BLOG
- APNACIRCLE
- Eurekamoments in Organic Chemistry
- Organic Chemistry by Dr Anthony
- Green Chemistry International
- Technology Transfer
- Stereochemistry
- Spectroscopy
- Polymorphism
- Reactions in Org Chem
- DR ANTHONY MELVIN CRASTO Ph.D
- Pharmaceuticals
- Medicinal chemistry
- Organic chemistry literature
- Patent related site
- Green chemistry
- Reagents
- R & D
- Molecules
- Heterocyclic chem
- Sourcing
- NEW DRUG APPROVALS
- WORLD DRUG TRACKER
- Green Chemistry International
- drug regulatory affairs international
- ORGANIC SPECTROSCOPY INTERNATIONAL
- ORGANIC SYNTHESIS INTERNATIONAL
- ALL ABOUT DRUGS
- ORGANIC CHEMISTRY INTERNATIONAL
- GOOGLE PLUS
- Drug Scaleup and Manufacturing International
- MEDICINAL CHEMISTRY INTERNATIONAL
- DRUG SYNTHESIS INTERNATIONAL
- SLIDESHARE
- DRUGS WEB
- GOOGLE SCHOLAR
- MEDCHEM-amcrasto
- ONE ORGANIC CHEMISTONE DAY
- DRUG PATENTS INTERNATIONAL
- MEDCHEM ANTHONY CRASTO
- MEDCHEM anthony crasto
- Gravatar
- ZING ME VIETNAM
- RESEARCH GATE
- AWARDS
Verified Services
Recent Comments
The Green ChemisTREE: 20 years after taking root with the 12 principles
The Green ChemisTREE: 20 years after taking root with the 12 principles
View original post 314 more words
Catalyst-free and solvent-free hydroboration of aldehydes — All About Drugs
Green Chem., 2018, Advance ArticleDOI: 10.1039/C8GC00042E, Communication Hanna Stachowiak, Joanna Kazmierczak, Krzysztof Kucinski, Grzegorz Hreczycho For the first time, a general method for catalyst-free and solvent-free hydroboration of various aldehydes has been developed Catalyst-free and solvent-free hydroboration of aldehydes Catalyst-free and solvent-free hydroboration of aldehydes Hanna Stachowiak,a Joanna Kaźmierczak,a Krzysztof Kucińskia and Grzegorz Hreczycho*a Author affiliations *Corresponding authors…
via Catalyst-free and solvent-free hydroboration of aldehydes — All About Drugs
4,4,5,5-Tetramethyl-2-phenethyl-1,3,2-dioxaborolane — ORGANIC SPECTROSCOPY INTERNATIONAL
4,4,5,5-tetramethyl-2-phenethyl-1,3,2-dioxaborolanehttp://orgsyn.org/demo.aspx?prep=v94p0234 4,4,5,5-Tetramethyl-2-phenethyl-1,3,2-dioxaborolane (1) has the following physical and spectroscopic properties: Rf = 0.47 (3:97, ethyl acetate:pentane), the checkers report the following values for 1: Rf = 0.09 (3:97 ethyl acetate:pentane); Rf = 0.52 (10% EtOAc in hexanes); Merck silica gel 60 F254 plate; mp 38-39 °C; 1H NMR pdf(CDCl3, 400 MHz) δ: 1.18 (t, J = 8.4 Hz, 2H), 1.26 (s, 12H), 2.79 (t, J = 8.0 Hz, 2H), 7.16-7.22 (m,…
via 4,4,5,5-Tetramethyl-2-phenethyl-1,3,2-dioxaborolane — ORGANIC SPECTROSCOPY INTERNATIONAL
High vitamin D levels may help prevent cancer — Med-Chemist
In continuation of my update on Vitamin D, The study reinforces the existing theory that vitamin D helps defend against certain cancers. Exposure to sunlight stimulates the production of vitamin D by our skin. Vitamin D contributes to calcium level maintenance in our bodies, which in turn helps teeth, muscles and bones remain healthy. Aside from established benefits of…
via High vitamin D levels may help prevent cancer — Med-Chemist
Cafestol
Cafestol, a Bioactive Substance in Coffee, Has Antidiabetic Properties in KKAy Mice https://lnkd.in/e7BxMkg
Cafesterol
- Molecular FormulaC20H28O3
- Average mass316.435 Da
-
(1S,4S,12S,13R,16S,17R)-17-(Hydroxymethyl)-12-methyl-8-oxapentacyclo[14.2.1.01,13.04,12.05,9]nonadeca-5(9),6-dien-17-ol(1S,4S,12S,13R,16S,17R)-17-(Hydroxymethyl)-12-methyl-8-oxapentacyclo[14.2.1.01,13.04,12.05,9]nonadeca-5(9),6-dien-17-ol(1S,4S,12S,13R,16S,17R)-17-(Hydroxyméthyl)-12-méthyl-8-oxapentacyclo[14.2.1.01,13.04,12.05,9]nonadéca-5(9),6-dién-17-ol(3bS,5aS,7R,10aR,10bS)-7-(hydroxymethyl)-10b-methyl-3b,4,5,6,7,8,9,10,10a,10b,11,12-dodecahydro-5a,8-methanocyclohepta[5,6]naphtho[2,1-b]furan-7-ol[3bS-(3ba,5ab,7b,8b-10aa,10bb)]-3b,4,5,6,7,8,9,10,10a,10b,11,12-Dodecahydro-7-hydroxy-10b-methyl-5a,8-methano-5aH-cyclohepta[5,6]-naphtho[2,1-b]furan-7-methanolCafesterol469-83-0 [RN]
Scientists identify health benefits of cafestol in coffee
Scientists have identified two compounds in coffee – cafestol and caffeic acid – that could someday lead to the development of new medications to better prevent and treat type 2 diabetes…
Drinking three to four cups of coffee per day has been shown to decrease the risk of developing type 2 diabetes.
Now, scientists report they have identified two compounds that contribute to this health benefit. Researchers say that this knowledge could someday help them develop new medications to better prevent and treat the disease.
Patients with type 2 diabetes become resistant to insulin, a hormone that helps turn glucose from food into energy. To overcome this resistance, the pancreas makes more insulin, but eventually, it just can’t make enough. High blood glucose levels can cause health problems, such as blindness and nerve damage.
Coffee’s cafestol has dual benefits
Several genetic and life style risk factors have been linked to the development of type 2 diabetes, but drinking coffee has been shown to help prevent its onset. Caffeine was thought to be responsible, but studies have shown it has only a short-term effect on glucose and insulin, and decaffeinated coffee has the same effect as the regular version of the drink. To investigate which of coffee’s many bioactive components are responsible for diabetes prevention, Søren Gregersen and colleagues tested the effects of different coffee substances in rat cell lines.
The researchers investigated different coffee compounds’ effects on cells in the lab. Cafestol and caffeic acid both increased insulin secretion when glucose was added. The team also found that cafestol increased glucose uptake in muscle cells, matching the levels of a currently prescribed antidiabetic drug. They say cafestol’s dual benefits make it a good candidate for the prevention and treatment of type 2 diabetes. However, because coffee filters eliminate much of the cafestol in drip coffee, it is likely that other compounds also contribute to these health benefits.
 |
|
| Names | |
|---|---|
| IUPAC name
(3bS,5aS,7R,8R,10aR,10bS)-3b,4,5,6,7,8,9,10,10a,10b,11,12-Dodecahydro-7-hydroxy-10b-methyl-5a,8-methano-5aH-cyclohepta[5,6]naphtho[2,1-b]furan-7-methanol
|
|
| Identifiers | |
|
3D model (JSmol)
|
|
| ChEBI | |
| ChemSpider | |
| KEGG | |
|
PubChem CID
|
|
| UNII | |
| Properties | |
| C20H28O3 | |
| Molar mass | 316.44 g·mol−1 |
| Melting point | 158 to 162 °C (316 to 324 °F; 431 to 435 K) |
|
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
|
|
 |
| Structural Formula Vector Image |
|
Title: Cafestol
CAS Registry Number: 469-83-0
CAS Name: [3bS-(3ba,5ab,7b,8b,10aa,10bb)]-3b,4,5,6,7,8,9,10,10a,10b,11,12-Dodecahydro-7-hydroxy-10b-methyl-5a,8-methano-5aH-cyclohepta[5,6]naphtho[2,1-b]furan-7-methanol
Additional Names: cafesterol
Molecular Formula: C20H28O3
Molecular Weight: 316.43
Percent Composition: C 75.91%, H 8.92%, O 15.17%
Literature References: Diterpenoid constituent of coffee. Isoln from green coffee oil: Slotta, Neisser, Ber. 71, 1991, 2342 (1938); C. Djerassi et al., J. Org. Chem. 18, 1449 (1953). Prepn and purification: R. Bertholet, US 4692534 (1987 to Nestec). Structure: C. Djerassi et al., J. Am. Chem. Soc. 81, 2386 (1959); R. A. Finnegan, C. Djerassi, ibid. 82, 4342 (1960). Stereochemical studies: R. A. Finnegan, J. Org. Chem. 26, 3057 (1961); A. I. Scott et al., J. Am. Chem. Soc. 84, 3197 (1962); A. I. Scott et al., Tetrahedron20, 1339 (1964). Stereospecific total synthesis of (±)-form: E. J. Corey et al., J. Am. Chem. Soc. 109, 4717 (1987).
Properties: Crystals from hexane, mp 158°-l60°. [a]D -101°. uv max: 222 nm (log e 3.78).
Melting point: mp 158°-l60°
Optical Rotation: [a]D -101°
Absorption maximum: uv max: 222 nm (log e 3.78)
Derivative Type: Acetate
Molecular Formula: C22H30O4
Molecular Weight: 358.47
Percent Composition: C 73.71%, H 8.44%, O 17.85%
Properties: Needles from petr ether, mp 167-168°. [a]D -89°. uv max: 222 nm (log e 3.80).
Melting point: mp 167-168°
Optical Rotation: [a]D -89°
Absorption maximum: uv max: 222 nm (log e 3.80)
Derivative Type: Tetrahydrocafestol
Molecular Formula: C20H32O3
Molecular Weight: 320.47
Percent Composition: C 74.96%, H 10.06%, O 14.98%
Properties: Crystals from dil methanol, mp 154.5-157°.
Melting point: mp 154.5-157°
|
//////////Cafesterol
CC12CCC3=C(C1CCC45C2CCC(C4)C(C5)(CO)O)C=CO3
Eating Nuts may dramatically improve Colon Cancer outcomes — ClinicalNews
Eating Nuts may dramatically improve Colon Cancer outcomes Those who regularly consumed at least two, one-ounce servings of nuts each week demonstrated a 42% improvement in disease-free survival and a 57% improvement in overall survival. Nut Consumption and Survival in Patients With Stage III Colon Cancer: Results From CALGB 89803 (Alliance). Journal of Clinical […]
via Eating Nuts may dramatically improve Colon Cancer outcomes — ClinicalNews
FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution
The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death. Continue reading.
FDA warns of fraudulent and unapproved flu products
FDA warns of fraudulent and unapproved flu products
As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies. Continue Reading
One hundred percent fruit juice does not alter blood sugar levels — Med-Chemist
The results are consistent with prior studies which have shown that consumption of 100% fruit juice is not linked to increasing risk of developing type 2 diabetes. It also supports a growing body of evidence that fruit juice has no significant impact on glycemic control.The study involved comprehensive data analysis that quantitatively evaluated the correlation between…
via One hundred percent fruit juice does not alter blood sugar levels — Med-Chemist
Novel Drug Approvals for 2017, A Review/Compilation
CDSCO
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
36 OZENOXACIN
40 SARILUMAB
41 SECNIDAZOLE
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;
• 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
| No. | Drug Name |
Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 46. | Giapreza | angiotensin II | 12/21/2017 | To increase blood pressure in adults with septic or other distributive shock |
| 45. | Macrilen | macimorelin acetate | 12/20/2017 | For the diagnosis of adult growth hormone deficiency |
| 44. | Steglatro | ertugliflozin | 12/19/2017 | To improve glycemic control in adults with type 2 diabetes mellitus |
| 43. | Rhopressa | netarsudil | 12/18/2017 | To treat glaucoma or ocular hypertension |
| 42. | Xepi | ozenoxacin | 12/11/2017 | To treat impetigo Drug Trials Snapshot |
| 41. | Ozempic | semaglutide | 12/5/2017 | To improve glycemic control in adults with type 2 diabetes mellitus |
| 40. | Hemlibra | emicizumab | 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. |
| 39. | Mepsevii | vestronidase alfa-vjbk | 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. |
| 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 |
| 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 SnapshotChemistry 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
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
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 |
-Facebook.png)
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 |
5 AVELUMAB
MERCK
| Bavencio | FDA 3/23/2017 | To treat metastatic Merkel cell carcinoma Press Release Drug Trials Snapshot |
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
7 Benznidazole
CHEMO RESEARCH
| benznidazole | FDA
8/29/2017 |
To treat children ages 2 to 12 years old with Chagas disease Press Release Drug Trials Snapshot |
8 BETRIXABAN
PORTOLA PHARMA
| Bevyxxa | FDA
6/23/2017 |
For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness Drug Trials Snapshot
|
9 BRIGATINIB
TAKEDA
| 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 |
10 BRODALUMAB
VALEANT PHARMA
| Siliq | FDA
2/15/2017 |
To treat adults with moderate-to-severe plaque psoriasis Press Release Drug Trials Snapshot |
LINK ,,,,https://newdrugapprovals.org/2017/02/16/fda-approves-new-psoriasis-drug-siliq-brodalumab/
11 CERLIPONASE ALFA
| Brineura | FDA 4/27/2017 | To treat a specific form of Batten disease Press Release Drug Trials Snapshot |
12 Copanlisib
| Aliqopa | FDA APPROVED
9/14/2017 |
To treat adults with relapsed follicular lymphoma Press Release Drug Trials Snapshot |
LINK…..https://newdrugapprovals.org/2017/11/20/copanlisib/
13 DEFLAZACORT
MARATHON PHARMA
| 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 |
LINK……..https://newdrugapprovals.org/2018/01/25/delafloxacin/
15 Deutetrabenazine
TEVA
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
| 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
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 |
19 EMICIZUMAB
ROCHE
| 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 |
20 Enasidenib
| Idhifa | FDA
8/1/2017 |
To treat relapsed or refractory acute myeloid leukemia Press Release Drug Trials Snapshot |
21 Ertugliflozin
MERCK
| 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/
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
guselkumab
FDA 7/13/2017
For the treatment of adult patients with moderate-to-severe plaque psoriasis
Drug Trials Snapshot
25 Inotuzumab ozogamicin
PFIZER
| Besponsa | FDA
8/17/2017 |
To treat adults with relapsed or refractory acute lymphoblastic leukemia Press Release Drug Trials Snapshot |
26 LATANOPROSTENE
VALEANT
latanoprostene bunod ophthalmic solution
FDA 11/2/2017
To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Drug Trials Snapshot
27 LETERMOVIR
MERCK
| 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 |
29 MEROPENEM
30 MIDOSTAURIN
NOVARTIS
- Chemistry Review(s) (PDF)
| Rydapt | FDA
4/28/2017 |
To treat acute myeloid leukemia Press Release Drug Trials Snapshot |
31 Naldemedine
FDA 3/23/2017, Symproic, For the treatment of opioid-induced constipation
32 NERATINIB MALEATE
PUMA BIOTECH
| Nerlynx | FDA | 7/17/2017 | To reduce the risk of breast cancer returning Press Release Drug Trials Snapshot |
33 NETARSUDIL
| Rhopressa | FDA APPROVED
12/18/2017 |
To treat glaucoma or ocular hypertension |
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 |
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 |
36 OZENOXACIN
MEDIMETRIX
| 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
| Trulance | FDA APPROVED
1/19/2017 |
To treat Chronic Idiopathic Constipation (CIC) in adult patients. Press Release Drug Trials Snapshot |
39 RIBOCICLIB
NOVARTIS
Structure..link for correct structure
| Kisqali | FDA 3/13/2017 | To treat postmenopausal women with a type of advanced breast cancer Drug Trials Snapshot |
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/
41 SECNIDAZOLE
SYMBIOMIX
| Solosec | FDA | 9/15/2017 | To treat bacterial vaginosis Drug Trials Snapshot |
42 SAFINAMIDE
NEWRON PHARMA
- Chemistry Review(s) (PDF) for correct structure
| Xadago | FDA 3/21/2017 | To treat Parkinson’s disease Press Release Drug Trials Snapshot |
43 Semaglutide
NOVO NORDISK
| 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/
44 SOFOSBUVIR
45 TELOTRISTAT ETHYL
LEXICON
| Xermelo | FDA
2/28/2017 |
To treat carcinoid syndrome diarrhea Press Release Drug Trials Snapshot |
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 |
47 VALBENAZINE
NEUROCRINE
- Chemistry Review(s) (PDF)
| Ingrezza | FDA
4/11/2017 |
To treat adults with tardive dyskinesia Press Release Drug Trials Snapshot |
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 |
49 VELPATASVIR
50 VOXILAPREVIR
GILEAD
| Vosevi | sofosbuvir, velpatasvir and voxilaprevir | FDA 7/18/2017 | To treat adults with chronic hepatitis C virus Press Release Drug Trials Snapshot |
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
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
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
SEE EMA
| Axumin : EPAR – Summary for the public | EN = English | 06/07/2017 |
27A Lutetium lu 177 dotatate
WILL BE UPDATED
34A NONACOG
WILL BE UPDATED
34B NUCINERSEN
EMA AND JAPAN 2017 APPROVED
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
38A PRALATREXATE
Japan approved 2017
| 2017/7/3 | PMDA | JAPAN | Pralatrexate | Difolta | Mundipharma | NME |
39A ROLAPITANT
WILL BE UPDATED
39B RURLOCTOCOG
WILL BE UPDATED
43A SODIUM ZIRCONIUM
WILL BE UPDATED
44A SPHEROX
WILL BE UPDATED
45A TIVOZANIB
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
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
45B TOFACITINIB
WILL BE UPDATED
45C TRUMENBA
WILL BE UPDATED
