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New Drug Approvals Archive - 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 (Trichuris trichiura), 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.

Humulin R (insulin human)

New Dosage Form Approved: December 29, 2015

Botox (onabotulinumtoxinA)

New Indication Approved: January 21, 2016

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.

Dexilant SoluTab (dexlansoprazole) Delayed-Release Orally Disintegrating Tablets

Date of Approval: January 26, 2016
Company: Takeda Pharmaceuticals U.S.A., Inc.
Treatment for: Gastroesophageal Reflux Disease

Dexilant SoluTab (dexlansoprazole) is a proton pump inhibitor (PPI) indicated for the treatment of patients with heartburn associated with gastroesophageal reflux disease (GERD).

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: Chronic 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

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.

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