FDA actions in brief

Briefs of FDA actions/approvals of drugs, doses, and indications

Key Points

Protein C concentrate (human) (Ceprotin, Baxter) was approved as replacement therapy in patients with life-threatening blood-clotting complications related to severe congenital Protein C deficiency.

H5N1 vaccine (Sanofi Pasteur) was approved for the prevention of H5N1 avian influenza.

FDA approved RhO(D) immune globulin intravenous (human) (Rhophylac, CSL Behring) for the treatment of immune thrombocytopenic purpura (ITP). This agent was previously approved for the prevention of hemolytic disease of the newborn and for the suppression of Rh isoimmunization in pregnancy and obstetric conditions and following an incompatible transfusion.

A new dose of risedronate (Actonel, Procter & Gamble/Sanofi-Aventis) was approved for the treatment and prevention of postmenopausal osteoporosis. The new dose will allow patients to take one 75-mg tablet daily on 2 consecutive days once per month.

A new 12.5-mg dose of risperidone (Risperdal Consta, Janssen) was approved for the treatment of schizophrenia within specific patient populations, including those with renal and hepatic impairment.

FDA has approved a new accelerated dosing schedule for hepatitis A (inactivated) and hepatitis B (recombinant) vaccine (Twinrix, GlaxoSmithKline). Three doses of the agent can now be administered within 3 weeks, followed by a booster dose at 12 months.