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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Kabiven (amino acids, electrolytes, dextrose and lipid) Injectable Emulsion

Company: Fresenius Kabi USA
Date of Approval: August 25, 2014
Treatment for: Parenteral Nutrition

Kabiven (amino acids, electrolytes, dextrose and lipid injectable emulsion) is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition.

Kabiven FDA Approval History

Triumeq (abacavir, dolutegravir and lamivudine) Tablets

Company: ViiV Healthcare
Date of Approval: August 22, 2014
Treatment for: HIV Infection

Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.

Triumeq FDA Approval History

Arnuity Ellipta (fluticasone furoate) Inhalation Powder

Company: GlaxoSmithKline plc
Date of Approval: August 20, 2014
Treatment for: Asthma, Asthma -- Maintenance

Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid for the maintenance treatment of asthma.

Arnuity Ellipta FDA Approval History

Cerdelga (eliglustat) Capsules

Company: Genzyme Corporation
Date of Approval: August 19, 2014
Treatment for: Gaucher Disease

Cerdelga (eliglustat) is a glucosylceramide synthase inhibitor indicated for the long- term treatment of adult patients with Gaucher disease type 1.

Cerdelga FDA Approval History

Plegridy (peginterferon beta-1a) Injection

Company: Biogen Idec
Date of Approval: August 15, 2014
Treatment for: Multiple Sclerosis

Plegridy (peginterferon beta-1a) is a pegylated interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Plegridy FDA Approval History

Belsomra (suvorexant) Tablets

Company: Merck, Sharpe & Dohme Corp.
Date of Approval: August 13, 2014
Treatment for: Insomnia

Belsomra (suvorexant) is an orexin receptor antagonist for use in patients with difficulty falling or staying asleep (insomnia).

Belsomra FDA Approval History

Invokamet (canagliflozin and metformin) Tablets

Company: Janssen Research & Development, LLC
Date of Approval: August 8, 2014
Treatment for: Diabetes Type 2

Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.

Invokamet FDA Approval History

Orbactiv (oritavancin) Injection

Company: The Medicines Company
Date of Approval: August 6, 2014
Treatment for: Skin and Structure Infection

Orbactiv (oritavancin) is a semi-synthetic lipoglycopeptide antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Orbactiv FDA Approval History

Jardiance (empagliflozin) Tablets

Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: August 1, 2014
Treatment for: Diabetes Type 2

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of type 2 diabetes.

Jardiance FDA Approval History

Striverdi Respimat (olodaterol) Inhalation Spray

Company: Boehringer Ingelheim Pharmaceuticals Inc.
Date of Approval: July 31, 2014
Treatment for: Chronic Obstructive Pulmonary Disease

Striverdi Respimat (olodaterol) is a once-daily, long-acting beta-agonist (LABA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Striverdi Respimat FDA Approval History

Acticlate (doxycycline hyclate) Tablets

Company: Aqua Pharmaceuticals, LLC
Date of Approval: July 25, 2014
Treatment for: Bacterial Infection, Acne

Acticlate (doxycycline hyclate) is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.

Acticlate FDA Approval History

Zydelig (idelalisib) Tablets

Company: Gilead Sciences, Inc.
Date of Approval: July 23, 2014
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma

Zydelig (idelalisib) is a phosphoinositide 3-kinase (PI3K) delta inhibitor for the treatment of chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma.

Zydelig FDA Approval History

Targiniq ER (naloxone and oxycodone) Extended-Release Tablets

Company: Purdue Pharma L.P.
Date of Approval: July 23, 2014
Treatment for: Pain

Targiniq ER (naloxone and oxycodone) is an opioid antagonist and opioid analgesic combination in a long-acting abuse-deterrent formulation for the management of chronic severe pain.

Targiniq ER FDA Approval History

Flonase Allergy Relief (fluticasone propionate) Nasal Spray

Company: GlaxoSmithKline plc
Date of Approval: July 23, 2014
Treatment for: Allergic Rhinitis

Flonase Allergy Relief (fluticasone propionate) is a once-a-day, over-the-counter corticosteroid nasal spray indicated for the relief hay fever symptoms.

Flonase Allergy Relief FDA Approval History

Ryanodex (dantrolene) Injectable Suspension

Company: Eagle Pharmaceuticals, Inc.
Date of Approval: July 22, 2014
Treatment for: Malignant Hyperthermia

Ryanodex (dantrolene) is a skeletal muscle relaxant in a concentrated formulation for the treatment of malignant hyperthermia.

Ryanodex FDA Approval History

Ruconest (C1 esterase inhibitor (recombinant)) - formerly Rhucin

Company: Pharming Group NV
Date of Approval: July 16, 2014
Treatment for: Angioedema

Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Ruconest FDA Approval History

Rasuvo (methotrexate) Injection - formerly MPI-2505

Company: Medac Pharma, Inc.
Date of Approval: July 11, 2014
Treatment for: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriasis

Rasuvo (methotrexate) is a subcutaneous, ready-to-use autopen formulation of methotrexate for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

Rasuvo FDA Approval History

Kerydin (tavaborole) Topical Solution

Company: Anacor Pharmaceuticals
Date of Approval: July 7, 2014
Treatment for: Onychomycosis -- Toenail

Kerydin (tavaborole) is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails.

Kerydin FDA Approval History

Beleodaq (belinostat) Injection

Company: Spectrum Pharmaceuticals, Inc.
Date of Approval: July 3, 2014
Treatment for: Peripheral T-cell Lymphoma

Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor for the treatment of peripheral T-cell lymphoma (PTCL).

Beleodaq FDA Approval History

Vazculep (phenylephrine hydrochloride) Injection

Company: Flamel Technologies
Date of Approval: June 27, 2014
Treatment for: Hypotension

Vazculep (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of hypotension resulting primarily from vasodilation in the setting of anesthesia.

Vazculep FDA Approval History
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