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New Drug Approvals Archive - August 2014

See also: New Indications and Dosage Forms for August 2014

August 2014

Jardiance (empagliflozin) Tablets

Date of Approval: August 1, 2014
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction, Heart Failure with Reduced Ejection Fraction

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of type 2 diabetes, to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease, and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.

Orbactiv (oritavancin) Injection

Date of Approval: August 6, 2014
Company: The Medicines Company
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).

Invokamet (canagliflozin and metformin) Tablets

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

Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination indicated for the treatment of type 2 diabetes, and to reduce the risk of cardiovascular events (including heart attack, stroke or death) in adults with type 2 diabetes and established cardiovascular disease.

Belsomra (suvorexant) Tablets

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

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

Plegridy (peginterferon beta-1a) Injection

Date of Approval: August 15, 2014
Company: Biogen Idec
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.

Cerdelga (eliglustat) Capsules

Date of Approval: August 19, 2014
Company: Genzyme Corporation
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.

Arnuity Ellipta (fluticasone furoate) Inhalation Powder

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

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

Triumeq (abacavir, dolutegravir and lamivudine) Tablets

Date of Approval: August 22, 2014
Company: ViiV Healthcare
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.

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

Date of Approval: August 25, 2014
Company: Fresenius Kabi USA
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.

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