In Brief: Effervescent famotidine
This article was originally published in The Tan Sheet
Executive Summary
Effervescent famotidine: ANDA suitability petitions for famotidine 10 mg and 5 mg effervescent tablets filed with FDA Sept. 12 by Budd Lake, N.J.-based regulatory strategist Thomas Blake on behalf of an unnamed client. Famotidine is the active ingredient in J&J/Merck's H2 antagonist Pepcid AC. The petition for the 5 mg tablets notes that two would be taken to equal a 10 mg dose equal to the amount contained in the listed drug. A similar petition has been submitted by Blake for a dual-tablet effervescent dose of ranitidine 75 mg ("The Tan Sheet" Sept. 15, p. 14)...