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Private label famotidine

This article was originally published in The Tan Sheet

Executive Summary

Cheminor Drugs receives tentative approval from FDA Dec. 13 for OTC famotidine 10 mg tablets (ANDA 75-758). Reference drug is J&J/Merck's Pepcid AC, which recently was granted additional six months of exclusivity based on pediatric data submitted by firm, postponing market entry of generic versions of H2 antagonist until April 15. Both Teva Pharmaceuticals and Danbury Pharmacal also have tentative approvals; Perrigo, PFI, Leiner and Zenith Goldline intend to offer generic famotidine in 2001 (1"The Tan Sheet" Nov. 27, p. 11)

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Generic Famotidine Launch Delayed By Pepcid AC Pediatric Exclusivity

Private label famotidine 10 mg products will not launch until after April 15 due to FDA's Nov. 21 decision to grant J&J/Merck an additional six months of marketing exclusivity for Pepcid AC after reviewing pediatric data submitted by the firm.

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