As an interim step in its ongoing review of thiazolidinedione cardiac safety, FDA has called for revised class labeling for the TZDs featuring strengthened warnings about the incidence of heart failure and contraindications for patients with existing heart failure

Sanofi-Aventis intends to resubmit its NDA for Zimulti (rimonabant) pending clarification of FDA's questions regarding its obesity claim. The firm announced it was withdrawing the application June 29, roughly two weeks after the agency's Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted against approval of the cannabinoid-1 receptor antagonist for weight loss

Policymakers should instead focus on increasing efficiencies in drug development, distribution and reimbursement, National Academies report says, while also seeking broad policies like HHS direct negotiation for drug prices in Medicare.