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J&J/Merck's Mevacor OTC Switch Appears To Be "Not Approvable" At FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck's receipt of a letter from FDA on the eve of the Feb. 24 user fee deadline, coupled with statements from the agency, suggest that FDA deemed the statin "not approvable" for OTC sale. Advisory committees voted against the switch in January.

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