NDAC joint panel planned
This article was originally published in The Tan Sheet
Executive Summary
FDA's drug center has tentatively scheduled a joint meeting of its Endocrinologic and Metabolic Drugs Advisory Committee and its Nonprescription Drugs Advisory Committee for Dec. 13 and 14. The agency will not discuss the planned topic until publishing a Federal Register notice announcing a confirmed meeting. Previously, the agency convened the same joint panel to consider the suitability of statins, including Merck's Mevacor (lovastatin) and Bristol-Myers Squibb's Pravachol (pravastatin) for OTC sale, and to review GlaxoSmithKline's weight-loss drug alli (orlistat) for an Rx-to-OTC switch. Bayer, which now holds the OTC rights for Pravachol, is pursuing an active program to switch the drug to OTC, while J&J/Merck is still seeking a switch for Mevacor (1"The Tan Sheet" July 2, 2007, In Brief)...