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Friday 25 January 2008
Market Report
Merck receives not approvable letter from FDA for OTC MEVACOR (lovastatin) 20 mg Co received a not approvable letter from the U.S Food and Drug Administration (FDA) to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR (lovastatin) 20 mg.
MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews in 2000 and 2005 resulted in not approvable actions. The FDA indicated in its letter that it would require a revised label and additional data from MRK in order to gain marketing approval.