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)...
You may also be interested in...
Orally Dissolving Strips To Melt Away Heartburn? ANDA Suitability Sought
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
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.