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New Drug Approvals Archive - August 2014

August 2014

Jardiance (empagliflozin) Tablets

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

Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Read more: Jardiance (empagliflozin) FDA Approval History

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).

Read more: Orbactiv (oritavancin) FDA Approval History

Invokamet (canagliflozin and metformin) Tablets

Date of Approval: August 8, 2014
Company: Janssen Research & Development, LLC
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.

Read more: Invokamet (canagliflozin and metformin) FDA Approval History

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).

Read more: Belsomra (suvorexant) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: August 14, 2014

Read more: Avastin (bevacizumab) FDA Approval History

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.

Read more: Plegridy (peginterferon beta-1a) FDA Approval History

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.

Read more: Cerdelga (eliglustat) FDA Approval History

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.

Read more: Arnuity Ellipta (fluticasone furoate) FDA Approval History

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.

Read more: Triumeq (abacavir, dolutegravir and lamivudine) FDA Approval History

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.

Read more: Kabiven (amino acids, electrolytes, dextrose and lipid) FDA Approval History

New Drug Approvals Archive