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

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Liletta (levonorgestrel) Intrauterine Device - formerly Levosert

Company: Medicines360 and Actavis plc
Date of Approval: February 27, 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

Triferic (ferric pyrophosphate citrate) Solution

Company: Rockwell Medical, Inc.
Date of Approval: January 23, 2015
Treatment for: Anemia Associated with Chronic Renal Failure

Triferic (ferric pyrophosphate citrate) is an iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

Triferic FDA Approval History

Bexsero (meningococcal group B vaccine) Injection

Company: Novartis Vaccines and Diagnostics Inc.
Date of Approval: January 23, 2015
Treatment for: Meningitis -- Meningococcal

Bexsero (meningococcal group B vaccine) is a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

Bexsero FDA Approval History

Cosentyx (secukinumab) Injection

Company: Novartis Pharmaceuticals Corporation
Date of Approval: January 21, 2015
Treatment for: Plaque Psoriasis

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of moderate-to-severe plaque psoriasis.

Cosentyx FDA Approval History

Prestalia (amlodipine besylate and perindopril arginine) Tablets

Company: Symplmed
Date of Approval: January 21, 2015
Treatment for: Hypertension

Prestalia (amlodipine besylate and perindopril arginine) is a calcium channel blocker and long-acting angiotensin-converting enzyme (ACE) inhibitor combination for the treatment of hypertension.

Prestalia FDA Approval History

Phoxillum (renal replacement solution)

Company: Baxter International Inc.
Date of Approval: January 13, 2015
Treatment for: Continuous Renal Replacement Therapy

Phoxillum (renal replacement solution) is a replacement solution used for electrolyte management in Continuous Renal Replacement Therapy (CRRT).

Phoxillum FDA Approval History

Duopa (carbidopa and levodopa) Enteral Suspension

Company: AbbVie Inc.
Date of Approval: January 12, 2015
Treatment for: Parkinson's Disease

Duopa (carbidopa and levodopa) is an aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination formulated as an enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

Duopa FDA Approval History

Savaysa (edoxaban) Tablets

Company: Daiichi Sankyo Company
Date of Approval: January 8, 2015
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Savaysa (edoxaban) is an oral, once-daily factor Xa inhibitor anticoagulant indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment of deep vein thrombosis, and pulmonary embolism.

Savaysa FDA Approval History

Rytary (carbidopa and levodopa) Extended Release Capsules - formerly IPX066

Company: Impax Laboratories, Inc.
Date of Approval: January 7, 2015
Treatment for: Parkinson's Disease

Rytary (carbidopa and levodopa) is an extended release aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination indicated for the treatment of Parkinson’s disease.

Rytary FDA Approval History
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