New Drug Approvals Archive - 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.

• FDA Approves Jardiance (empagliflozin) to Treat Type 2 Diabetes

Jardiance (empagliflozin) FDA Approval History

Lumizyme (alglucosidase alfa)

Patient Population Altered: August 1, 2014

• FDA Expands Approval of Lumizyme to treat Pompe Disease Patients of All Ages

Lumizyme (alglucosidase alfa) 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).

• FDA Approves Orbactiv (oritavancin) to Treat Skin and Skin Structure Infections

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.

• FDA Approves Invokamet (canagliflozin/metformin) for Type 2 Diabetes

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).

• FDA Approves Belsomra (suvorexant) for Insomnia

Belsomra (suvorexant) FDA Approval History

Avastin (bevacizumab)

New Indication Approved: August 14, 2014

• FDA Approves Avastin for Metastatic Cervical Cancer

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.

• FDA Approves Plegridy (peginterferon beta-1a) for the Treatment of Multiple Sclerosis

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.

• FDA Approves Cerdelga (eliglustat) for Type 1 Gaucher Disease

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.

• FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

Arnuity Ellipta (fluticasone furoate) FDA Approval History

Eliquis (apixaban)

New Indication Approved: August 21, 2014

• FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Eliquis (apixaban) 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.

• FDA Approves Triumeq for the Treatment of HIV-1 Infection

Triumeq (abacavir, dolutegravir and lamivudine) FDA Approval History

Zorvolex (diclofenac)

New Indication Approved: August 22, 2014

• Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain

Zorvolex (diclofenac) FDA Approval History

Promacta (eltrombopag)

New Indication Approved: August 26, 2014

• FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia

Promacta (eltrombopag) 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.

• Fresenius Kabi Receives FDA Approval for Kabiven and Perikabiven

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

Invokamet (canagliflozin and metformin)

Labeling Revision Approved: May 20, 2016

• FDA Expands Indication of Invokamet (canagliflozin/metformin HCl) to Include First-Line Treatment of Type 2 Diabetes

Invokamet (canagliflozin and metformin) FDA Approval History

Invokamet (canagliflozin and metformin)

New Dosage Form Approved: September 20, 2016

• FDA Approves Invokamet XR (Canagliflozin/Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes

Invokamet (canagliflozin and metformin) FDA Approval History

Jardiance (empagliflozin)

New Indication Approved: December 2, 2016

• FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes

Jardiance (empagliflozin) FDA Approval History