Home > Newsletters > Drug Industry Daily > Jazz Petitions FDA, Alleges Agency Wrongly Accepted Xyrem ANDA
Drug Industry Daily
July 27, 2012 | Vol. 11 No. 147
Jazz Petitions FDA, Alleges Agency Wrongly Accepted Xyrem ANDA
Jazz Pharmaceuticals is calling on the FDA to rescind its acceptance of Roxane Laboratories’ ANDA for a generic version of Jazz’s narcolepsy drug Xyrem, saying the FDA prematurely accepted the application, violating federal law and harming Jazz and other potential ANDA sponsors.
FDA Questions Reckitt’s Motives in Petition Denial, OKs Suboxone ANDAsTwo Ex-FDA Commissioners Say Generic Makers Don’t Get Free Pass on State Suits Actavis Hit with Infringement Suit Following Fortesta ANDA Submission FDA Questions Reckitt Benckiser’s Motives in Petition Denial, OKs Two Suboxone Generics
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.