Pepcid AC
This article was originally published in The Tan Sheet
Executive Summary
Generic versions of market-leading H2 antagonist have yet to receive final approval, FDA says. Cheminor Drugs, Danbury Pharmacal and Teva Pharmaceuticals all have tentatively approved ANDAs for famotidine 10 mg; J&J/Merck product lost marketing exclusivity April 15. As first to receive tentative approval (on Oct. 15, 1998), Teva could be granted 180 days of private label exclusivity, although FDA's decision remains unmade. Leiner, Perrigo, PFI and Zenith Goldline also plan to introduce generic famotidine in 2001
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Perrigo's private label famotidine 10 mg was approved by FDA May 31, ending a drawn out delay of the generic launch.
Perrigo Famotidine Approved With Six Month Exclusivity; Shipments Begin
Perrigo's private label famotidine 10 mg was approved by FDA May 31, ending a drawn out delay of the generic launch.