H2s
This article was originally published in The Tan Sheet
Executive Summary
Famotidine orally disintegrating tablets cleared for ANDA submission by FDA in April 17 letter to Yamanouchi Pharma; firm filed citizen petition in July requesting authorization to change dosage form of J&J/Merck's Pepcid AC (1"The Tan Sheet" Aug. 7, 2000, p. 3). Pepcid AC lost exclusivity April 15. Also, agency gives green light to ANDA filing for generic nizatidine. Lachman Consultant Services filed citizen petition in April 2000 on behalf of unnamed drug maker to permit application for private label capsule form of Whitehall-Robins' Axid AR, for which exclusivity expired April 1. Leiner recently said it would not file an ANDA due to perceived lack of demand (2"The Tan Sheet" April 2, In Brief)
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Axid AR
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
J&J/Merck Pepcid AC Orally Disintegrating Tablets In The Works
J&J/Merck is looking to extend its category-leading Pepcid AC franchise with an orally disintegrating dosage form developed by Yamanouchi Pharma Technologies.
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