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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)...

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Bayer HealthCare is "working with the FDA" on its planned Rx-to-OTC switch of Bristol-Myers Squibb's cholesterol drug, Pravachol, Gary Balkema, the firm's Consumer Care Division president, says June 19. During Bayer's investor conference in Leverkusen, Germany, Balkema said gaining FDA approval for low-dose Pravachol is the division's top switch priority. "Companies that have the ability to introduce switches see some significant growth opportunities and we plan to be one of those companies," he said, adding Bayer will "explore additional switch opportunity projects." Bayer acquired U.S. marketing rights for a switch of the statin in 2004 (1"The Tan Sheet" Dec. 13, 2004, p. 5). An advisory panel review would be the second time around for pravastatin, which went before a joint panel in 2000 and failed to gain approval from the agency, as did Merck's Mevacor (lovastatin). The agency's Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees again voted against J&J and Merck's switch proposal for Mevacor in 2005 (2"The Tan Sheet" Jan. 17, 2005, p. 3). Following the vote, Merck has worked with FDA on labeling to be tested for an OTC Mevacor and on testing methodologies (3"The Tan Sheet" March 20, 2006, p. 4)...

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