FDA advisory panel rejects OTC status for Merck's Mevacor

December 17, 2007

FDA advisory panel rejects Merck's bid for OTC Mevacor

A panel of FDA advisors has voted 10-2 to recommend that the FDA reject Merck & Co.'s latest bid to take its cholesterol-lowering prescription drug Mevacor over-the-counter. The advisors felt that patients may not understand how to use the drug properly. This was Merck's third request to make the medication available OTC. During a press briefing at the conclusion of the panel meeting, Andrea Leonard Segal, M.D., and director of the Division of Nonprescription Clinical Evaluation, at FDA's Office of Nonprescription Products, said, "We've just heard the advisory committee's views on the application to make Mevacor 20 mg, which is currently a prescription drug, an OTC drug. The committee discussed the safety of 20 mg and the ability of consumers to make a proper choice to use Mevacor if it were to be an OTC drug. Now we are going to take what we've heard from the committee and we are going to go back and think about it and discuss it. We always take the committee's advice carefully into consideration and they have raised some important points for us to think about. The discussion was very interesting and brought up lots of things for us to consider."

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