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This article was originally published in The Tan Sheet

Executive Summary

Famotidine orally disintegrating tablets cleared for ANDA submission by FDA in April 17 letter to Yamanouchi Pharma; firm filed citizen petition in July requesting authorization to change dosage form of J&J/Merck's Pepcid AC (1"The Tan Sheet" Aug. 7, 2000, p. 3). Pepcid AC lost exclusivity April 15. Also, agency gives green light to ANDA filing for generic nizatidine. Lachman Consultant Services filed citizen petition in April 2000 on behalf of unnamed drug maker to permit application for private label capsule form of Whitehall-Robins' Axid AR, for which exclusivity expired April 1. Leiner recently said it would not file an ANDA due to perceived lack of demand (2"The Tan Sheet" April 2, In Brief)

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