Orally Dissolving Strips To Melt Away Heartburn? ANDA Suitability Sought
This article was originally published in The Tan Sheet
An orally disintegrating strip form of Johnson & Johnson/Merck's Pepcid AC (famotidine 10 mg) could be heading towards the market if FDA looks favorably upon a pending ANDA suitability petition
You may also be interested in...
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)...
A generic version of Pfizer's Zyrtec-D 12 Hour is among the Paragraph IV abbreviated new drug applications submitted to FDA early this summer
Warner-Lambert Consumer Healthcare's Cool Mint Listerine PocketPaks, claimed to kill the germs that cause bad breath, feature a new delivery system - quickly dissolving translucent strips that are placed on the tongue.