Private label famotidine
This article was originally published in The Tan Sheet
Executive Summary
Teva Pharmaceuticals receives tentative approval from FDA Oct. 15 for OTC famotidine 10 mg tablets (ANDA 75-312). The reference drug is J&J/Merck's Pepcid AC, the leading OTC stomach remedy product according to Chicago-based Information Resources, Inc. Perrigo also plans to launch a generic version of Pepcid AC when its marketing exclusivity expires Aug. 11, 2000. J&J/Merck recently launched ads for its chewable version of Pepcid AC ("The Tan Sheet" Oct. 26, In Brief). The product was approved at the end of September