FDA Actions in Brief January 2011 (Amturnide, Prezista, Safyral, Gardasil, Atelvia)

Recent FDA Approvals (through December 2010) related to Amturnide, Prezista, Safyral, Gardasil, Atelvia

A triple-combination pill containing aliskiren, amlodipine, and hydrochlorothiazide (Amturnide, Novartis) was approved for patients whose high blood pressure is not adequately controlled with any 2 of its individual components.

A new dosing protocol was approved for darunavir (Prezista, Tibotec Therapeutics) in combination with ritonavir for the treatment of HIV-1, to include once-daily (800/100 mg) dosing in treatment-experienced adult patients with no darunavir resistance-associated mutations.

Drospirenone 3 mg/ethinyl estradiol 30 μg/levomefolate calcium 451 μg tablets and levomefolate 451 μg tablets (Safyral, Bayer HealthCare Pharmaceuticals) was approved as an oral contraceptive and also raises folate levels in women who choose an oral contraceptive for birth control for the purpose of reducing the risk of rare neural tube defects in a pregnancy conceived while taking Safyral or shortly after discontinuing it.

Risedronate sodium (Atelvia, Warner Chilcott), the first oral bisphosphonate taken weekly immediately after breakfast, was approved for the treatment of postmenopausal osteoporosis.