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New Drug Approvals Archive - August 2012

See also: New Indications and Dosage Forms for August 2012

August 2012

Zaltrap (ziv-aflibercept) Injection

Date of Approval: August 3, 2012
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Colorectal Cancer

Zaltrap (ziv-aflibercept) is an angiogenesis inhibitor for the combination treatment of patients with metastatic colorectal cancer.

Marqibo (vincristine sulfate liposomes) Injection - formerly Onco TCS

Date of Approval: August 9, 2012
Company: Talon Therapeutics Inc.
Treatment for: Acute Lymphoblastic Leukemia

Marqibo (vincristine sulfate liposome injection) is a vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL).

Auvi-Q (epinephrine) Injection

Date of Approval: August 10, 2012
Company: Sanofi
Treatment for: Anaphylaxis, Allergic Reaction

Auvi-Q (epinephrine injection) is a voice-guided epinephrine auto-injector for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis.

Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) Tablets

Date of Approval: August 27, 2012
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) is a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.

Granix (tbo-filgrastim) Injection

Date of Approval: August 29, 2012
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Neutropenia Associated with Chemotherapy

Granix (tbo-filgrastim) is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Linzess (linaclotide) Capsules

Date of Approval: August 30, 2012
Company: Allergan, Inc.
Treatment for: Irritable Bowel Syndrome, Constipation -- Chronic

Linzess (linaclotide) is a guanylate cyclase-C agonist indicated in adults for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

Xtandi (enzalutamide) Capsules

Date of Approval: August 31, 2012
Company: Astellas Pharma Inc.
Treatment for: Prostate Cancer

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer.

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