FDA Actions in Brief-September 2013


FDA approvals

Extended-release formulation of topiramate (Trokendi XR, Supernus Pharmaceuticals) was approved for the treatment of epilepsy.

Influenza Virus Vaccine (Flulaval Quadrivalent, GlaxoSmithKline) was approved for the active immunization of persons aged 3 years and older to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B contained in the vaccine.

Dolutegravir (Tivicay, ViiV Healthcare , GlaxoSmithKline) was approved to treat HIV-1 infection.

Enalapril maleate Powder for Oral Solution (Epaned, SIlvergate Pharmaceuticals) was approved to treat hypertension in patients aged 1 month and older.

The first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens (The Alere Determine HIV-1/2 Ag/Ab Combo, Orgenics, Ltd. (an Alere, Inc. company) was approved. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, this test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.

New formulations of butalbital, acetaminophen and caffeine capsules, USP (Fioricet, Actavis) and butalbital acetaminophen, caffeine and codeine phosphate, USP (Fioricet with Codeine, Actavis) containing a lower dose of acetaminophen were approved to provide safer treatment options for patients with tension (or muscle contraction) headaches.

Extended-release formulation of tacrolimus (Astagraf XL, Astellas Pharma) was approved for preventing kidney transplant rejection.

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