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Hemwall on Mevacor

This article was originally published in The Tan Sheet

Executive Summary

"I really don't want to read any more in 'The Tan Sheet' once a week about the 20-3 vote on the approvability question" regarding the proposed Rx-to-OTC switch of 20 mg Mevacor, J&J/Merck VP-Scientific & Regulatory Affairs Ed Hemwall quipped during the Consumer Healthcare Products Association's Regulatory & Scientific Conference in Washington, D.C. May 5. Hemwall spoke at the FDA advisory committee meeting on the switch application in January (1"The Tan Sheet" Jan. 17, 2005, p. 3). Despite the panel's recommendation against approval, the sponsor "made a lot of very good progress," Hemwall said. "We also had several 25-0 votes on major safety and efficacy issues," such as muscle and liver safety and drug interactions, he noted. "It [comes back to] understanding consumer behavior...that's the final piece of information that's going to be needed if a drug of this type is ever going to switch"...

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