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Pepcid Rx-to-OTC switch

Executive Summary

FDA's Nonprescription Drugs & Gastrointestinal Drugs Advisory Committees will consider J&J/Merck's application for over-the- counter status of the H[2]-antagonist Pepcid (famotidine) on July 29. J&J/Merck is seeking approval for the drug as an OTC for treatment and prevention of episodic heartburn. SmithKline Beecham is seeking OTC status for a similar indication for Tagamet (cimetidine); the advisory committees rejected an approval recommendation last September. However, SmithKline expects the OTC Tagamet NDA to be revisited on July 27. FDA has not yet officially announced a meeting on Tagamet
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PS024684

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