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

1 Abaloparatide

2 Abemaciclib

3 ACALABRUTINIB

4 ANGIOTENSIN II

5 AVELUMAB

6 BENRALIZUMAB

7 BENZNIDAZOLE

8 BETRIXABAN

9 BRIGATINIB

10 BRODALUMAB

11 CERLIPONASE ALPA

12 COPANLISIB

13 DEFLAZACORT

14 Delafloxacin

15 Deutetrabenazine

16DUPILUMAB

17 DURVALUMAB

18 EDAVARONE

19 EMICIZUMAB

20 Enasidenib

21 ERTUGLIFLOZIN

22 ETELCALCETIDE

23 GLECAPREVIR

24 GUSELKUMAB

25 INOTUZUMAB OZOGAMICIN

26 LATANOPROSTENE

27 LETERMOVIR

28 MACIMORELIN ACETATE

29 MEROPENEM

30 MIDOSTAURIN

31 NALDEMEDINE

32 NERATINIB

33 NETARSUDIL

34 NIRAPARIB

35 Ocrelizumab

36 OZENOXACIN

37 PIBRENTASVIR

38 PLECANATIDE

39 RIBOCICLIB

40  SARILUMAB

41 SECNIDAZOLE

42 SAFINAMIDE

43 SEMAGLUTIDE

44 SOFOSBUVIR

45 TELOTRISTAT ETHYL

46 VABORBACTAM

47 VALBENAZINE

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

* 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

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

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

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

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

5 AVELUMAB

MERCK

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

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

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

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 Chemistry Review(s) (PDF)

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

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

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

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

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

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

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

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

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/

20 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

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

Tremfya

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

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

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

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

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

30 MIDOSTAURIN

NOVARTIS

• Chemistry Review(s) (PDF)

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

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

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

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

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

36 OZENOXACIN

MEDIMETRIX

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

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

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

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

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

• 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

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

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

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

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

• Chemistry Review(s) (PDF)

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

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

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

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

27A Lutetium lu 177 dotatate

WILL BE UPDATED

34A NONACOG

WILL BE UPDATED

34B NUCINERSEN

EMA AND JAPAN 2017 APPROVED

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

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

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

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

Publication details

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

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/

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………………………………………..

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

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

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

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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,