(By Balachander) Jazz Pharmaceuticals Plc (NASDAQ: JAZZ) shares retreated in early Wednesday trade after after the U.S. health regulators denied its Citizens Petition.
The Dublin-based company had in May submitted a Citizen Petition to the U.S. Food & Drug Administration addressing the legal and scientific bases for requiring in vivo bioequivalence studies for generic formulations of Xyrem (sodium oxybate) oral solution.
XYREM is a FDA-approved medication for the treatment of excessive (too much) daytime sleepiness and the treatment of cataplexy (weak or paralyzed muscles), both in patients with narcolepsy.
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Jazz requsted the FDA publish bioequivalence requirements specifying whether in vitro or in vivo bioequivalence studies, or both, are required for abbreviated new drug applications (ANDAs) referencing Xyrem
The company also requested that the FDA not accept any generic versions for review until the FDA has published the bioequivalence requirements.
Further, Jazz disclosed that the FDA response did not address its Citizen Petition filed on July 10. The petition asks the FDA to rescind the acceptance of any previously-accepted ANDA referencing Xyrem, including the ANDA filed by Roxane Laboratories Inc.
The company believes that the FDA's premature acceptance of Roxane's ANDA caused the thirty-month stay under the Hatch-Waxman Act and the related patent litigation between the parties to begin prematurely in a manner contrary to the law, a regulatory filing made in July showed.
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The stock, which has been trading in a 52-week range of $34.39 to $60.00, shed 3.76 percent to trade at $50.94 on Wednesday.