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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

Nuplazid (pimavanserin) Tablets

Company: Acadia Pharmaceuticals Inc.
Date of Approval: April 29, 2016
Treatment for: Parkinson’s Disease Psychosis

Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.

Nuplazid FDA Approval History

Akovaz (ephedrine sulfate)

Company: Flamel Technologies
Date of Approval: April 29, 2016
Treatment for: Hypotension

Akovaz (ephedrine sulfate) is a pressor agent administered parenterally to address clinically important hypotension in surgical settings.

Akovaz FDA Approval History

Cabometyx (cabozantinib) Tablets

Company: Exelixis, Inc.
Date of Approval: April 25, 2016
Treatment for: Renal Cell Carcinoma

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti­-angiogenic therapy.

Cabometyx FDA Approval History

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) Inhalation Aerosol

Company: AstraZeneca Pharmaceuticals LP
Date of Approval: April 25, 2016
Treatment for: Chronic Obstructive Pulmonary Disease

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) is a long -acting beta2-adrenergic agonist (LABA) and anticholinergic combination indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Bevespi Aerosphere FDA Approval History

Venclexta (venetoclax) Tablets

Company: AbbVie Inc.
Date of Approval: April 11, 2016
Treatment for: Chronic Lymphocytic Leukemia

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion.

Venclexta FDA Approval History

BromSite (bromfenac) Ophthalmic Solution

Company: Sun Pharmaceutical Industries Ltd.
Date of Approval: April 8, 2016
Treatment for: Postoperative Ocular Inflammation

BromSite (bromfenac) is a low dose nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution for the treatment of inflammation and prevention of pain in patients undergoing cataract surgery.

BromSite FDA Approval History

Inflectra (infliximab-dyyb) Injection

Company: Celltrion, Inc.
Date of Approval: April 5, 2016
Treatment for: Crohn's Disease -- Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Inflectra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Inflectra FDA Approval History

Descovy (emtricitabine and tenofovir alafenamide) Tablets

Company: Gilead Sciences, Inc.
Date of Approval: April 4, 2016
Treatment for: HIV Infection

Descovy (emtricitabine and tenofovir alafenamide) is a nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection.

Descovy FDA Approval History

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 patients with hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

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
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