Perrigo Famotidine Approved With Six Month Exclusivity; Shipments Begin
This article was originally published in The Tan Sheet
Executive Summary
Perrigo's private label famotidine 10 mg was approved by FDA May 31, ending a drawn out delay of the generic launch.
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Famotidine
FDA approves ANDA 75-512 for Ivax' generic equivalent to J&J/Merck's Pepcid AC July 26, Miami-based company reports. Ivax famotidine 10 mg is first to carry heartburn prevention claim. Teva Pharmaceuticals received ANDA approval for a heartburn treatment claim May 31, according to FDA; firm licenses its version to Perrigo for sale in U.S. (1"The Tan Sheet" June 4, p. 7). Cheminor Drugs and Danbury Pharmacal have received tentative approval