New Drug Approvals Archive - January 2016
See also: New Indications and Dosage Forms for January 2016
January 2016
Emverm (mebendazole) Chewable Tablets
Date of Approval: January 15, 2016
Company: Impax Laboratories, Inc.
Treatment for: Pinworm Infection (Enterobius vermicularis), Whipworm Infection, Hookworm Infection (Necator or Ancylostoma), Ascariasis
Emverm (mebendazole) is a chewable tablet formulation of the approved anthelmintic mebendazole for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.
Adzenys XR-ODT (amphetamine) Extended-Release Orally Disintegrating Tablets
Date of Approval: January 27, 2016
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit Hyperactivity Disorder (ADHD)
Adzenys XR-ODT (amphetamine) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
Onzetra Xsail (sumatriptan) Inhalation Powder - formerly AVP-825
Date of Approval: January 27, 2016
Company: Avanir Pharmaceuticals, Inc.
Treatment for: Migraine
Onzetra Xsail (sumatriptan) is a fast-acting, intranasal serotonin 5-HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura.
Zepatier (elbasvir and grazoprevir) Tablets
Date of Approval: January 28, 2016
Company: Merck & Co., Inc.
Treatment for: Hepatitis C
Zepatier (elbasvir and grazoprevir) is a once-daily, single tablet, NS5A replication complex inhibitor and NS3/4A protease inhibitor combination for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections.
Zembrace SymTouch (sumatriptan) Injection
Date of Approval: January 28, 2016
Company: Dr. Reddy’s Laboratories Ltd.
Treatment for: Migraine
Zembrace SymTouch (sumatriptan) is a selective 5-HT1B/ID receptor agonist in a prefilled, ready-to-use, single-dose disposable autoinjector for the treatment of acute migraine episodes, with or without aura.
Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution
Date of Approval: January 29, 2016
Company: Arbor Pharmaceuticals, LLC
Treatment for: Acetaminophen Overdose
Marketing Status: Discontinued
Cetylev (acetylcysteine) is an antidote for acetaminophen overdose indicated to prevent or lessen liver damage after the ingestion of a potentially hepatotoxic quantity of acetaminophen.
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
- 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.