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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Sernivo (betamethasone dipropionate) Topical Spray

Company: Promius Pharma, LLC
Date of Approval: February 5, 2016
Treatment for: Plaque Psoriasis

Sernivo Spray (betamethasone dipropionate) is a topical corticosteroid indicated for the treatment of mild to moderate plaque psoriasis.

Sernivo FDA Approval History

Zepatier (elbasvir and grazoprevir) Tablets

Company: Merck & Co., Inc.
Date of Approval: January 28, 2016
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.

Zepatier FDA Approval History

Zembrace SymTouch (sumatriptan) Injection

Company: Dr. Reddy’s Laboratories Ltd.
Date of Approval: January 28, 2016
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.

Zembrace SymTouch FDA Approval History

Adzenys XR-ODT (amphetamine) Extended-Release Orally Disintegrating Tablets

Company: Neos Therapeutics, Inc.
Date of Approval: January 27, 2016
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.

Adzenys XR-ODT FDA Approval History

Dexilant SoluTab (dexlansoprazole) Delayed-Release Orally Disintegrating Tablets

Company: Takeda Pharmaceuticals U.S.A., Inc.
Date of Approval: January 26, 2016
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).

Dexilant SoluTab FDA Approval History

Emverm (mebendazole) Chewable Tablets

Company: Impax Laboratories, Inc.
Date of Approval: January 15, 2016
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.

Emverm FDA Approval History

Zurampic (lesinurad) Tablets

Company: AstraZeneca Pharmaceuticals LP
Date of Approval: December 22, 2015
Treatment for: Hyperuricemia Associated with Gout

Zurampic (lesinurad) is a URAT1 inhibitor indicated for the combination treatment of hyperuricemia associated with gout.

Zurampic FDA Approval History

Docetaxel Non-Alcohol Formula Injection

Company: Eagle Pharmaceuticals, Inc.
Date of Approval: December 22, 2015
Treatment for: Cancer

Docetaxel Injection, Non-Alcohol Formula is an alcohol-free formulation of docetaxel for use in the treatment of patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

FDA Approval History

Uptravi (selexipag) Tablets

Company: Actelion Pharmaceuticals US, Inc.
Date of Approval: December 21, 2015
Treatment for: Pulmonary Arterial Hypertension

Uptravi (selexipag) is an oral prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension.

Uptravi FDA Approval History

Basaglar (insulin glargine) Injection

Company: Eli Lilly and Company and Boehringer Ingelheim
Date of Approval: December 16, 2015
Treatment for: Diabetes Type 1, Diabetes Type 2

Basaglar (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in patients with type 1 and type 2 diabetes mellitus.

Basaglar FDA Approval History

Vistogard (uridine triacetate) Oral Granules

Company: Wellstat Therapeutics Corporation
Date of Approval: December 11, 2015
Treatment for: Fluorouracil Overdose and Capecitabine Overdose

Vistogard (uridine triacetate) is a pyrimidine analog indicated for the emergency treatment of adults and children who receive an overdose of the cancer treatments fluorouracil or capecitabine.

Vistogard FDA Approval History

Alecensa (alectinib) Capsules

Company: Genentech, Inc.
Date of Approval: December 11, 2015
Treatment for: Non-Small Cell Lung Cancer

Alecensa (alectinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Alecensa FDA Approval History

Otiprio (ciprofloxacin) Otic Suspension - formerly AuriPro

Company: Otonomy, Inc.
Date of Approval: December 10, 2015
Treatment for: Tympanostomy Tube Placement Surgery

Otiprio (ciprofloxacin otic suspension) is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery.

Otiprio FDA Approval History

Kanuma (sebelipase alfa) Injection

Company: Alexion Pharmaceuticals, Inc.
Date of Approval: December 8, 2015
Treatment for: Lysosomal Acid Lipase Deficiency

Kanuma (sebelipase alfa) is an enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D).

Kanuma FDA Approval History

Vonvendi (von willebrand factor (recombinant)) for Injection

Company: Baxalta Incorporated
Date of Approval: December 8, 2015
Treatment for: von Willebrand's Disease

Vonvendi [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (VWF) indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease.

Vonvendi FDA Approval History

QuilliChew ER (methylphenidate hydrochloride) Extended Release Chewable Tablets

Company: Pfizer Inc.
Date of Approval: December 7, 2015
Treatment for: Attention Deficit Hyperactivity Disorder

QuilliChew ER (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

QuilliChew ER FDA Approval History

Bendeka (bendamustine hydrochloride) Injection

Company: Eagle Pharmaceuticals, Inc.
Date of Approval: December 7, 2015
Treatment for: Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma

Bendeka (bendamustine hydrochloride) is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Bendeka FDA Approval History

Empliciti (elotuzumab) Injection

Company: Bristol-Myers Squibb Company and AbbVie
Date of Approval: November 30, 2015
Treatment for: Multiple Myeloma

Empliciti (elotuzumab) is a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Empliciti FDA Approval History
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