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FDA Says Mevacor OTC Label Needs “Major Revisions”

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency review finds only 1% of respondents in a label comprehension study correctly said they could use lovastatin 20 mg “right away.” OTC Division’s Ganley cites concerns in a letter to the Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees, which will review J&J/Merck’s Rx-to-OTC switch application.

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