We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Jazz Petition Alleges Agency Wrongly Accepted Xyrem ANDA
Jazz Petition Alleges Agency Wrongly Accepted Xyrem ANDA
July 27, 2012
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.