Axid AR
This article was originally published in The Tan Sheet
Executive Summary
H2 antagonist loses marketing exclusivity April 1; Whitehall-Robins said it does not plan to seek six months of pediatric exclusivity. It appears there will be little private label competition, however; Leiner Health Products said Axid's sales are not strong enough to warrant developing generic nizatidine, and no tentatively approved ANDAs are listed on FDA's Web site. J&J/Merck's Pepcid AC (famotidine) loses pediatric exclusivity April 15