Duragesic Pediatric Exclusivity: Diflucan Precedent Should Delay Mylan’s Generic, J&J Says
This article was originally published in The Pink Sheet Daily
Executive Summary
In a letter to FDA, J&J points to the Pfizer/Ranbaxy dispute over the scope of pediatric exclusivity for Diflucan in arguing that Mylan’s Paragraph IV certification for the fentanyl patch should be treated as a Paragraph II certification and subject to the innovator’s six-month pediatric extension.