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FDAnews Drug Daily Bulletin
Aug. 9, 2012 | Vol. 9 No. 156
Jazz Petition Alleges FDA 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. According to Jazz, 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. The approval required a medication guide and a risk management program — or what is now deemed to be a risk evaluation and mitigation strategy (REMS).
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