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J&J-MERCK PEPCID AC OTC LABEL WILL CLAIM 75% EFFICACY IN PREVENTION OF HEARTBURN; FIRST OTC H2 ANTAGONIST WILL BE AVAILABLE ON RETAIL SHELVES BY SUMMER

Executive Summary

Pepcid AC will carry claims of 70% relief and 75% prevention in an OTC patient labeling insert when it reaches retail shelves this June. FDA approved the Rx-to-OTC switch application from Merck (NDA #20-325) for famotidine in packages of 6, 12 and 18 tabs (10 mg) on April 28, 27 months after the initial submission of the NDA and nine months after an FDA advisory committee asked for statistical reanalysis of data.
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PS026136

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