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Consumer OTC Drugs

J&J/Merck Pepcid AC first chewable H2 is latest twist in stomach remedy market.

This article was originally published in The Tan Sheet

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Executive Summary

J&J/MERCK PEPCID AC CHEWABLE TABLETS "APPROVABLE" at FDA as of Dec. 19 under NDA 20-801. The NDA is separate from the original application for the OTC H2 antagonist for prevention and treatment of heartburn that was approved in April 1995. If there are no glitches and the new NDA is approved, Pepcid AC would be the first chewable H2 antagonist on the market. J&J/Merck's interest in capturing market share by introducing a new delivery system reflects the rapid maturation of H2 antagonists as the brand name marketers get ready to compete with private label products such as those from Perrigo, Granutec and PFI ("The Tan Sheet" Nov. 17, 1997, p. 12). The approvable NDA presumably covers 10 mg famotidine chewable tablets.

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