New Drug Approvals Archive - September 2016
See also: New Indications and Dosage Forms for September 2016
September 2016
Cuvitru (immune globulin subcutaneous (human)) Injection
Date of Approval: September 13, 2016
Company: Shire plc
Treatment for: Primary Immunodeficiency Syndrome
Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).
Yosprala (aspirin and omeprazole) Delayed-Release Tablets
Date of Approval: September 14, 2016
Company: Aralez Pharmaceuticals Inc.
Treatment for: Ischemic Stroke -- Prophylaxis, Gastric Ulcer Prophylaxis
Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
Exondys 51 (eteplirsen) Injection
Date of Approval: September 19, 2016
Company: Sarepta Therapeutics
Treatment for: Duchenne Muscular Dystrophy
Exondys 51 (eteplirsen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.
Kyleena (levonorgestrel) Releasing Intrauterine System
Date of Approval: September 16, 2016
Company: Bayer
Treatment for: Contraception
Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to five years.
Lomaira (phentermine hydrochloride) Tablets
Date of Approval: September 13, 2016
Company: KVK Tech, Inc.
Treatment for: Weight Loss, Obesity
Lomaira (phentermine hydrochloride) is a sympathomimetic amine anorectic used short-term for weight reduction in overweight or obese adults.
Amjevita (adalimumab-atto) Injection - formerly ABP 501
Date of Approval: September 23, 2016
Company: Amgen Inc.
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohn's Disease -- Maintenance, Psoriatic Arthritis, Juvenile Idiopathic Arthritis
Amjevita (adalimumab-atto) an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
New Drug Approvals Archive
- 2021
- January, February
- 2020
- January, February, March, April, May, June, July, August, September, October, November, December
- 2019
- January, February, March, April, May, June, July, August, September, October, November, December
- 2018
- January, February, March, April, May, June, July, August, September, October, November, December
- 2017
- January, February, March, April, May, June, July, August, September, October, November, December
- 2016
- January, February, March, April, May, June, July, August, September, October, November, December
- 2015
- January, February, March, April, May, June, July, August, September, October, November, December
- 2014
- January, February, March, April, May, June, July, August, September, October, November, December
- 2013
- January, February, March, April, May, June, July, August, September, October, November, December
- 2012
- January, February, March, April, May, June, July, August, September, October, November, December
- 2011
- January, February, March, April, May, June, July, August, October, November, December
- 2010
- January, February, March, April, May, June, July, August, September, October, November, December
- 2009
- January, February, March, April, May, June, July, August, September, October, November, December
- 2008
- January, February, March, April, May, June, July, August, September, October, November, December
- 2007
- January, February, March, April, May, June, July, August, September, October, November, December
- 2006
- January, February, March, April, May, June, July, August, September, October, November, December
- 2005
- January, February, March, April, May, June, July, August, September, October, November, December
- 2004
- January, February, March, April, May, June, July, August, September, October, November, December
- 2003
- January, February, March, April, May, June, July, August, September, October, November, December
- 2002
- January, February, April, May, July, August, October, November, December
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.