New Drug Approvals Archive - January 2016

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))

Patient Population Altered: January 14, 2016

• FDA Approves Expanded Use of GSK Hib Vaccine From Booster Dose To Full Series

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) FDA Approval History

Cosentyx (secukinumab)

New Indication Approved: January 15, 2016

• Novartis Receives FDA Approval for Cosentyx (secukinumab) to Treat Patients with Ankylosing Spondylitis and Psoriatic Arthritis

Cosentyx (secukinumab) FDA Approval History

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.

• Impax Receives Approval of Emverm (mebendazole) Chewable Tablets

Emverm (mebendazole) FDA Approval History

Arzerra (ofatumumab)

Labeling Revision Approved: January 15, 2016

• Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) as Extended Treatment for Recurrent or Progressive CLL

Arzerra (ofatumumab) FDA Approval History

Dalvance (dalbavancin)

New Dosage Regimen: January 21, 2016

• Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin)

Dalvance (dalbavancin) FDA Approval History

Humulin R (insulin human)

New Dosage Form Approved: December 29, 2015

• U.S. Food And Drug Administration Approves Humulin R U-500 KwikPen

Kyprolis (carfilzomib)

New Indication Approved: January 21, 2016

• FDA Approves New Kyprolis (Carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Kyprolis (carfilzomib) FDA Approval History

Botox (onabotulinumtoxinA)

New Indication Approved: January 21, 2016

• FDA Approves Botox (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity

Opdivo (nivolumab)

New Indication Approved: January 23, 2016

• Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status

Opdivo (nivolumab) FDA Approval History

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.

• Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for ADHD

Adzenys XR-ODT (amphetamine) FDA Approval History

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).

• FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

Dexilant SoluTab (dexlansoprazole) FDA Approval History

Halaven (eribulin mesylate)

New Indication Approved: January 28, 2016

• FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma

Halaven (eribulin mesylate) FDA Approval History

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-HT_1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura.

• FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine

Onzetra Xsail (sumatriptan) FDA Approval History

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.

• FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4

Zepatier (elbasvir and grazoprevir) FDA Approval History

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-HT_1B/ID receptor agonist in a prefilled, ready-to-use, single-dose disposable autoinjector for the treatment of acute migraine episodes, with or without aura.

• Dr. Reddy’s Laboratories Ltd. Receives FDA Approval for Zembrace SymTouch (sumatriptan succinate) Injection for the Acute Treatment of Migraines

Zembrace SymTouch (sumatriptan) FDA Approval History

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.

• Arbor Pharmaceuticals Announces FDA Approval of Cetylev

Cetylev (acetylcysteine) FDA Approval History