Pediatric CVD Report Slights Nutrition’s Role, Weighs On OTC Statin Chances
This article was originally published in The Tan Sheet
An American Academy of Pediatrics report recommending prescribing statin drugs for cardiovascular disease in children could present another roadblock for switching statins to OTC
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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.....
More information from "real world" experiences on how consumers make OTC selections may be needed to pull off a successful Rx-to-OTC switch of a statin