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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