Novel Drug Approvals for 2017
Drug Name:Novel Drug Approvals for 2017
List Of Brands:
Indication Type Description:
Indication
Indication:
Novel Drug Approvals for 2017
(For more salient details please refer the Drug)
No. Drug Name Active Ingred. Apprvl Date FDA Approved use on approved date
M- Manufacturer D- Distributor
1. Trulance Plecanatide Jan 2017 To treat Chronic Idiopathic Constipation (CICC) in adult patients
2.Parsalbiv Etelcacenatide Feb 2017 To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis
3.Emflaza Deflazocort Feb 2017 To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD)
M for: Marathon Pharmaceuticals, LLC Northbrook, IL, 60062 U.S.A. EMFLAZA Oral Suspension made in Spain PC####X Feb 2017 EMFLAZATM is a trademark of Marathon Pharmaceuticals, LLC.
4.Siliq Brodalumab Feb 2017 To treat dults with moderate-to-severe plaque psoriasis
5. Xermelo Telotristat ethyl Feb 2017 To treat carcinoid syndreome
6.Kisquali Ribociclib Mar 2017 To treat postmenopausal women with a type of advanced breast cancer
D by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
7.Xadago Safinamide Mar 2017 To treat Parkinson's disease
9.Synproic Nademedine Mar 2017 For the treatment of opiod-induced constipation
10.Zejula Niraparib Mar 2017 For the maintenance treatment for or primary peritoneal cancers
11.Dupixent Dupilumab Mar 2017 To treat adult with moderate-to-severe ezema (atopic dermatitis)
12. Ocrevus Ocrelizumab Mar 2017 To treat patients with relapsing and primary progressive formas of multiple sclerosis
13.Austedo Deutetrabenazine Apr 2017 For the treatment of chorea associated with Huttington's disease
14.Ingressa Valbemazine Apr 2017 To treat adults with tardive dyskinesia
15.Brineura Cerliponase Apr 2017 To treat specific form of Batten disease alfa
M by: BioMarin Pharmaceutical Inc.Novato, CA 94949
16.ALunbrig Brigatinib Apr 2017 To treat patients with analastic lymphoma kinase (ALK) -positive metastic non- small cell lung cancer (NSCLC) who have progressed on or are intolerent to crizotinib
17.Rydapt Midostaurin Apr 2017 To treat acute myeliod leukemia
18. Tymlos Abaloparatide Apr 2017 To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies
19.Imfinzi Durvalumab May 2017 To treat patients with locally advanced or metastatic urothelial carcinoma
20.Rdicava Edaravone May 2017 To treat patients with amyotrophic lateral sclerosis (ALS)
22. Baxdela Delfloxacin June 2017 To treat patients with acute bacterial skin infections
23. BEVYXXA Betrixaban June 2017 For the prophylaxis of venous thromboenbolism (VTE ) in adult patients hospitalized for an acute medical illness
24.Tremfya Guselkumab July 2017 For the treatment of adult patients with moderate-to-severe plaque psoriasis
Product of USA M by: Janssen Biot
25.Nerlynx Neratinib July 2017 To reduce the risk of breast cancer Maleate treturning
D by Puma Biotechnology, Inc. 10880 Wilshire Blvd., Suite 2150 Los Angeles, CA 90024-4106 ©2017, Puma Biotechnology
26.Vosevi Sofosbuvir, July 2017 To treat adults with chronic hepatitis Velpatasvir and C virus Voxillaprevir
M d and D by:Gilead Sciences, Inc. Foster City, CA 94404 VOSEVI, GENVOYA, HARVONI, and ODEFSEY are trademarks of Gilead Science
27.Idhifa Enasidenib Aug 2017 To treat relapsed or refractory acute myeloid leukemia
M for and Mk by:Celgene Corporation Summit, NJ 07901
28.Mavret Glecaprevir Aug 2017 To treat adults with chronic hepatitis and Pibrentasvir C virus
M by AbbVie Inc., North Chicago, IL 60064 MAVYRET is a trademark of AbbVie Inc.
29.Besponsa Inotuzumab Aug 2017 To treat adults with relapsed or efractory Ozogamicin refractory acute lymphoblastic leukemia
M by Wyeth pharmaceuticals Inc
30.Vabomere Meropenem Aug 2017 To treat adults with complicated urinary and Vaborbactam infections
M by:Facta Farmaceutici, S.p.A. Teramo, 64100, Italy Mk by: The Medicines Company Parsippany, NJ 07054
31.Benznidazole Benznidazole Aug 2017 To treat children ages 12 years old with Chagas disease
M for Chemo Research, S.L. Madrid, Spain M by Laboratorios Liconsa S.A. Guadalajara, Spain D by: Exeltis USA, Inc. Florham Pa
32.Aliquopa Copanlisib Sep 2017 To treat adults with relapsed follicular lymphoma
M for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 USA © 2017 Bayer H
33. Solosec Secnidazole Sep 2017 To treat bacterial vaginosis
D by: Symbiomix Therapeutics LLC Newark, NJ 07103 M by: Catalent Pharma Solutions Somerset, NJ 08873
34.Verzenio Abemaciclib Sep 2017 To treat certain advanced ormetastic breast cancer
M by:Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © 2017, 2018, Eli Lilly and Company.
35.Calquence Acalabrutinib Oct 2017 To treat adults with mantle cell lymphoma
D-by: AstraZeneca Pharmaceuticals Wilmington,Wilmington, DE 19850 Under license of Acerta Pharma B.V. CALQUENCE is a registered trademark of the AstraZeneca group of companies.
36.Vyzulta Latanoprostene Nov 2017 To treat intraocular pressure in bunoid ophthalmic patients with open angle ma or solution glaucoma or ocular hypertension
37.Prevymis Letermovir Nov 2017 To prevent infection aftedr bone marrow transplant
38.Fasenra Benralizmab Nov 2017 For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophillic phenotype
39.Mesevii Vestronidase alfa Nov 2017 To treat pediatric and adult patients - vjbk with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII) also known as Sly syndrome
40.Hemlibra Emicizumab Nov 2017 To prevent or reduce the frequency of bleeding with hemophilia A who have developed antibodies called Factor VIII (F VIII) inhibitors
41.Ozempic Semaglutide Dec 2017 To improve glycemic control in adults with type 2 diabetes mellitus
42.Xepi Ozenoxacin Dec 2017 To treat impetigo
43. Rhopressa Netarsudil Dec 2017 To treat glaucoma or ocular hypertension
44.Steglatro Ertugliflozin Dec 2017 To improve glycemic control in adults with type 2 diabets mellitus
45.Macrilen Macimorelin Dec 2017 For the diagnosis of adult growth acetate hormone deficiency
46.Glapreza Angiotensin II Dec 2017 To increase blood pressure in adults with septic or other distributive shock
