Skip to main content

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: Birth Control

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

2022
January, February, March, April, May
2021
January, February, March, April, May, June, July, August, September, October, November, December
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

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.

Medical Disclaimer