FDA actions in brief

A new once-weekly formulation of alendronate in combination with 2,800 IU of vitamin D3 (Fosamax Plus D, Merck) was approved by FDA. The combination is indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.

FDA asked 14 manufacturers of antiepileptic drugs (AEDs) to re-evaluate clinical data to determine whether patients taking AEDs may have an increased risk of suicide. The drug makers have 6 months to respond to the request, which was issued in March 2005.

A liquid formulation of intravenous Rho(D) immune globulin (human) (WinRho SDF, Cangene) received FDA approval. The therapy is indicated for the treatment of immune thrombocytopenic purpura (ITP).

A fluocinolone intravitreal implant (Retisert, Bausch & Lomb) was approved for the treatment of uveitis.

FDA issued a final guidance on pharmacogenomic data submissions. The guidance explains the submission format, what data will be needed during the marketing application review process, and what data will be used in making regulatory decisions.

Bortezomib (Velcade, Millennium) was approved for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. This action marks the full approval of bortezomib in treating relapsed multiple myeloma.

FDA approved mometasone inhalation powder (Asmanex Twisthaler, Schering-Plough) as a first-line maintenance treatment for asthma. Mometasone inhalation powder was also approved for use in patients who have received other drugs for the treatment of asthma.

Ondansetron injection (Zofran, GlaxoSmithKline) received approval for the prevention of nausea and vomiting associated with general anesthesia in children aged 1 month and older and in children aged 6 months and older who have nausea and vomiting associated with chemotherapy.

FDA's Nonprescription Drugs and Dermatologic & Ophthalmic Drugs advisory committees voted 21 to 5 that any topical corticosteroid that causes hypothalamic, pituitary, and adrenal (HPA) axis suppression under maximal use conditions is not an appropriate over-the-counter candidate.