Not Approvable Letter Issued on OTC Lovastatin

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Merck has received a not approvable letter from the FDA to its New Drug Application seeking approval for over-the-counter (OTC) Mevacor (lovastatin) 20 mg.

 

Mevacor OTC had been under review by the agency since 1999; reviews by advisory committees in 2000 and 2005 resulted in not approvable actions. The FDA indicated in the letter that it would require additional data and a revised label from Merck before granting marketing approval.

 

“We're evaluating the conditions outlined in the agency's response to determine a path forward for Mevacor OTC,” said Edwin L. Hemwall, PhD, Merck's vice president for global OTC regulatory and

scientific affairs.

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