August 2009 Issues

FDA Advisory Committee Recommends Approval of Amgen’s Osteoporosis Drug but has Safety Concerns -- Quick Pulse

Summary: The FDA.s Reproductive Health Drugs Advisory Committee (RHDAC) recommended approval of Amgen.s Prolia (denosumab) as a twice-a-year subcutaneous injection for the treatment of osteoporosis in postmenopausal women as well as for the treatment of bone loss in some patients undergoing hormone ablation therapy for prostate cancer who are losing bone mass. The panel determined that the drug is effective at increasing bone mineral density (BMD) and reducing the risk of fractures but did not recommend approval for four of the six proposed indications because of the potential for serious side effects and new tumors.

FDA Moves a Step Closer to Approving the First Generic Oral Vancomycin -- Quick Pulse

Summary: The FDA has proposed – and an advisory committee has agreed – that human clinical trials should not be required for some generic oral vancomycin products. The FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP) met on August 4, 2009, to discuss the use of in vitro dissolution methods to establish bioequivalence for generic vancomycin oral capsule drug products. It was a very technical topic, and discussion was limited to generic versions of just this antibiotic, but the meeting had important implications for ViroPharma and for generic manufacturers hoping to get FDA approval for a generic version of ViroPharma’s Vancocin.