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FDA Actions in Brief August 2012

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Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)

The 2012-2013 influenza (flu) vaccine formulation (Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corp.; FluMist, MedImmune Vaccines; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone, Fluzone High-Dose, and Fluzone Intradermal, Sanofi Pasteur) was approved for the 2012-2013 influenza season.

Ranibizumab injection (Lucentis, Genentech) was approved for treatment of diabetic macular edema, a sight-threatening eye disease that occurs in people with diabetes.

Vincristine sulfate liposome injection (Marqibo, Talon Therapeutics) was approved for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following 2 or more anti-leukemia therapies.

Ziv-aflibercept (Zaltrap, Sanofi and Regeneron Pharmaceuticals) injection was approved for intravenous infusion, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.

Prednisone (Rayos, Horizon Pharma) delayed-release tablets (1 mg, 2 mg, and 5 mg) were approved to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.

Aclidinium bromide inhalation powder (Tudorza Pressair, Forest Pharmaceuticals) was approved for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Carfilzomib (Kyprolis, Onyx Pharmaceuticals) was approved to treat patients with multiple myeloma who have received at least 2 prior therapies, including treatment with bortezomib (Velcade, Takeda) and an immunomodulatory therapy.

Everolimus (Afinitor, Novartis) was approved for use in combination with exemestane (Aromasin, Pfizer) to treat certain postmenopausal women with advanced hormone-receptor positive HER2-negative breast cancer.

Oxacillin for injection, USP (Sagent Pharmaceuticals), in 3 latex-free, preservative-free vial presentations, was approved for the treatment of infections caused by penicillinase producing staphylococci, which have demonstrated susceptibility to the drug.

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