Pepcid AC ANDA?
This article was originally published in The Tan Sheet
Executive Summary
An FDA response letter dated July 6 deems that famotidine 10 mg (J&J/Merck's Pepcid AC) in an orally dissolving strip formulation is suitable for ANDA submission. Approval of the application would mark the first time the strip technology would be used to deliver a drug, though many breath fresheners including Pfizer's Listerine PocketPaks already are available in the formulation. The petition, filed by Lachman Consultant Services on behalf of an unnamed firm, was submitted in August 2004 (1"The Tan Sheet" Aug. 16, 2004, p.10)...
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