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Merck’s Mevacor not approved

This article was originally published in The Tan Sheet

Executive Summary

FDA found Merck's third Rx-to-OTC switch application for OTC cholesterol-lowering Mevacor Daily (lovastatin/20mg) "not approvable." In a Jan. 25 release, the firm said FDA's letter responding to its application indicated the drug's approval would require "a revised label and additional data from Merck in order to gain marketing approval." "We are evaluating the conditions put forth by the agency in the letter to determine a path forward, and no decision is made at this time for the future of our Mevacor efforts," a spokesman forthe Whitehouse, N.J.-based firm told "The Tan Sheet." At a Dec. 13 meeting, FDA advisory committees recommended against approving the switch. The firm was also unsuccessful in gaining OTC approval for the drug in 2000 and 2005.....

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