Pill Identifier App

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

Get news by email or subscribe to our news feeds.

Jadenu (deferasirox)

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 30, 2015
Treatment for: Iron Overload

Jadenu (deferasirox) is a tablet formulation of Exjade, an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.

Jadenu FDA Approval History

Anthrasil (Anthrax Immune Globulin Intravenous (Human)) Injection

Company: Cangene Corporation
Date of Approval: March 24, 2015
Treatment for: Inhalation Anthrax

Anthrasil [Anthrax Immune Globulin Intravenous (Human)] is an immune globulin used to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

Anthrasil FDA Approval History

Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV Vaccine) Injection

Company: Sanofi Pasteur
Date of Approval: March 24, 2015
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis Prophylaxis, Pertussis Prophylaxis

Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) is a vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

Quadracel FDA Approval History

Cholbam (cholic acid) Capsules

Company: Asklepion Pharmaceuticals LLC
Date of Approval: March 17, 2015
Treatment for: Bile Acid Synthesis Disorders

Cholbam (cholic acid) is a bile acid preparation for the treatment of patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

Cholbam FDA Approval History

Unituxin (dinutuximab) Injection

Company: United Therapeutics Corporation
Date of Approval: March 10, 2015
Treatment for: Neuroblastoma

Unituxin (dinutuximab) is a chimeric monoclonal antibody used for the treatment of pediatric neuroblastoma.

Unituxin FDA Approval History

Zarxio (filgrastim-sndz) Injection

Company: Sandoz
Date of Approval: March 6, 2015
Treatment for: Neutropenia Associated with Chemotherapy

Zarxio (filgrastim-sndz) is a leukocyte growth factor biosimilar to the reference product Neupogen, indicated for the treatment of neutropenia associated with chemotherapy.

Zarxio FDA Approval History

Cresemba (isavuconazonium) Capsules and Injection

Company: Astellas Pharma US, Inc.
Date of Approval: March 6, 2015
Treatment for: Aspergillosis - Invasive, Mucormycosis - Invasive

Cresemba (isavuconazonium) is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis.

Cresemba FDA Approval History

Elepsia XR (levetiracetam) Extended-Release Tablets

Company: Sun Pharma Advanced Research Company Ltd.
Date of Approval: March 2, 2015
Treatment for: Epilepsy

Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures.

Elepsia XR FDA Approval History

Liletta (levonorgestrel) Intrauterine Device - formerly Levosert

Company: Medicines360 and Actavis plc
Date of Approval: February 26, 2015
Treatment for: Contraception

Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to three years.

Liletta FDA Approval History

Toujeo (insulin glargine [rDNA origin]) Injection

Company: Sanofi
Date of Approval: February 25, 2015
Treatment for: Diabetes Type 1, Diabetes Type 2

Toujeo (insulin glargine [rDNA origin] is a once-daily long-acting basal insulin used to improve glycemic control in adults with type 1 and type 2 diabetes.

Toujeo FDA Approval History

Avycaz (avibactam and ceftazidime) Injection

Company: Actavis plc
Date of Approval: February 25, 2015
Treatment for: Intraabdominal Infection, Urinary Tract Infection

Avycaz (avibactam and ceftazidime) is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin antibiotic combination for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.

Avycaz FDA Approval History

Farydak (panobinostat) Capsules - formerly LBH589

Company: Novartis Pharmaceuticals Corporation
Date of Approval: February 23, 2015
Treatment for: Multiple Myeloma

Farydak (panobinostat) is a histone deacetylase inhibitor for the combination treatment of multiple myeloma.

Farydak FDA Approval History

Lenvima (lenvatinib) Capsules

Company: Eisai Co., Ltd.
Date of Approval: February 13, 2015
Treatment for: Thyroid Cancer

Lenvima (lenvatinib) is an oral multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of progressive radioiodine-refractory differentiated thyroid cancer.

Lenvima FDA Approval History

Dutrebis (lamivudine and raltegravir) Tablets

Company: Merck
Date of Approval: February 6, 2015
Treatment for: HIV Infection

Dutrebis (lamivudine and raltegravir) is a fixed-dose combination of a nucleoside analog reverse transcriptase inhibitor and an integrase strand transfer inhibitor for the treatment of HIV-1 infection. Dutrebis will NOT be made commercially available in the U.S. at this time.

Dutrebis FDA Approval History

Glyxambi (empagliflozin and linagliptin) Tablets

Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company
Date of Approval: January 30, 2015
Treatment for: Diabetes Type 2

Glyxambi (empagliflozin and linagliptin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor combination for the treatment of adults with type 2 diabetes.

Glyxambi FDA Approval History

Pazeo (olopatadine hydrochloride) Ophthalmic Solution

Company: Alcon Laboratories, Inc.
Date of Approval: January 30, 2015
Treatment for: Allergic Conjunctivitis

Pazeo (olopatadine hydrochloride) is a mast cell stabilizer for the treatment of ocular itching associated with allergic conjunctivitis.

Pazeo FDA Approval History

Prezcobix (cobicistat and darunavir) Tablets

Company: Janssen Research & Development, LLC
Date of Approval: January 29, 2015
Treatment for: HIV Infection

Prezcobix (darunavir and cobicistat) is a once-daily fixed-dose combination containing a protease inhibitor and a pharmacokinetic enhancer for the treatment of HIV-1 infection.

Prezcobix FDA Approval History

Evotaz (atazanavir and cobicistat) Tablets

Company: Bristol-Myers Squibb Company
Date of Approval: January 29, 2015
Treatment for: HIV Infection

Evotaz (atazanavir and cobicistat) is a once-daily fixed-dose combination of a protease inhibitor and a pharmacokinetic enhancer for the treatment of HIV-1 infection.

Evotaz FDA Approval History

Natpara (parathyroid hormone) Injection

Company: NPS Pharmaceuticals, Inc.
Date of Approval: January 23, 2015
Treatment for: Hypoparathyroidism

Natpara (parathyroid hormone) is recombinant human parathyroid hormone 1-84 indicated to control hypocalcemia in patients with hypoparathyroidism.

Natpara FDA Approval History
Older articles
Hide
(web2)