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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

Defitelio (defibrotide) Injection

Company: Jazz Pharmaceuticals plc
Date of Approval: March 30, 2016
Treatment for: Hepatic Veno-Occlusive Disease

Defitelio (defibrotide sodium) is a deoxyribonucleic acid derivative anticoagulant for the treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation.

Defitelio FDA Approval History

Cinqair (reslizumab) Injection

Company: Teva Pharmaceutical Industries Ltd.
Date of Approval: March 23, 2016
Treatment for: Asthma

Cinqair (reslizumab) is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with eosinophilic asthma.

Cinqair FDA Approval History

Taltz (ixekizumab) Injection

Company: Eli Lilly and Company
Date of Approval: March 22, 2016
Treatment for: Plaque Psoriasis

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis.

Taltz FDA Approval History

Anthim (obiltoxaximab) Injection

Company: Elusys Therapeutics, Inc.
Date of Approval: March 18, 2016
Treatment for: Anthrax Prophylaxis, Inhalation Bacillus anthracis

Anthim (obiltoxaximab) is a monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax.

Anthim FDA Approval History

Kovaltry (antihemophilic factor (recombinant)) Injection

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: March 16, 2016
Treatment for: Hemophilia A

Kovaltry (antihemophilic factor (recombinant)) is a human DNA sequence derived, full length Factor VIII concentrate indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

Kovaltry FDA Approval History

Evomela (melphalan) for Injection

Company: Spectrum Pharmaceuticals, Inc.
Date of Approval: March 10, 2016
Treatment for: Multiple Myeloma

Evomela (melphalan) is an alkylating agent used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

Evomela FDA Approval History

Idelvion (coagulation factor IX (recombinant), albumin fusion protein) Injection

Company: CSL Behring
Date of Approval: March 4, 2016
Treatment for: Hemophilia B

Idelvion (coagulation factor IX (recombinant), albumin fusion protein) is a long-acting recombinant human blood coagulation factor indicated for the control and prevention of bleeding episodes in patients with hemophilia B.

Idelvion FDA Approval History

Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) Tablets

Company: Gilead Sciences, Inc.
Date of Approval: March 1, 2016
Treatment for: HIV Infection

Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is a fixed-dose combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), indicated as a complete regimen for the treatment of HIV-1 infection.

Odefsey FDA Approval History

Briviact (brivaracetam) Tablets, Solution and Injection

Company: UCB, Inc.
Date of Approval: February 19, 2016
Treatment for: Epilepsy

Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam indicated for the treatment of partial-onset seizures in patients with epilepsy.

Briviact FDA Approval History

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

Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution

Company: Arbor Pharmaceuticals, LLC
Date of Approval: January 29, 2016
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.

Cetylev 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
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