FDA Actions in Brief December 2012


Recent FDA Approvals (through December 2012) related to (Bedaquiline, Janssen, Oseltamivir, Genetech, Apixaban, Bristol-Myers Squibb, Lomitapide, Aegerion, Varicella zoster immune globulin preparation, Cangene, Teduglutide, NPS Pharmaceuticals, Pasireotide diaspartate, Novartis, Ponatinib, ARIAD Pharmaceuticals, Influenza virus vaccine, GlaxoSmithKline, Raxibacumab, Crofelemer, Salix, Cabozantinib, Exelixis)

Bedaquiline (Sirturo, Janssen, a Johnson & Johnson subsidiary) was approved as part of combination therapy to treat adults with multidrug-resistant pulmonary tuberculosis when other alternatives are not available.

Oseltamivir (Tamiflu, Genetech) expanded use was approved to treat children as young as aged 2 weeks old who have shown symptoms of flu for no longer than 2 days.

Apixaban (Eliquis, Bristol-Myers Squibb, BMS, and Pfizer) was approved to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation that is not caused by a heart valve problem.

Lomitapide (Juxtapid, Aegerion) capsules were approved as an adjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL)apheresis where available, to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and non-high-density-lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia.

Varicella zoster immune globulin preparation (Varizig, Cangene) was approved to reduce the severity of chicken pox infections in high-risk individuals when given within 4 days after exposure.

Teduglutide (Gattex, NPS Pharmaceuticals) was approved to treat adults with short bowel syndrome who need additional nutrition from intravenous feeding.

Pasireotide diaspartate (Signifor, Novartis Pharma Stein AG) injection was approved for the treatment of Cushing’s disease patients who cannot be helped through surgery.

Ponatinib (Iclusig, ARIAD Pharmaceuticals) was approved to treat adults with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), 2 rare bone marrow diseases.

Influenza virus vaccine (Fluarix Quadrivalent, GlaxoSmithKline) was approved for the immunization of children aged 3 years and older and adults to help prevent disease caused by seasonal influenza virus subtypes A and type B contained in the vaccine.

Raxibacumab (Human Genome Sciences, recently acquired by GlaxoSmithKline) was approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Raxibacumab was discovered and developed in conjunction with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services.

Crofelemer (Fulyzaq, Salix, under license from Napo Pharmaceuticals) was approved to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.

Cabozantinib (Cometriq, Exelixis) was approved to treat medullary thyroid cancer that has spread to other parts of the body.

First seasonal influenza vaccine (Flucelvax, Novartis Vaccines and Diagnostics GmbH) licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs, was approved to prevent seasonal influenza in people aged 18 years and older.

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