FDAnews Drug Daily Bulletin

Jazz Petition Alleges Agency Wrongly Accepted Xyrem ANDA

Aug. 6, 2012
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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. Sodium oxybate, the active ingredient in Xyrem, is a controlled substance and Jazz’s Xyrem 2002 approval came with a number of agency-imposed restrictions on the drug’s distribution and use.
Washington Drug Letter