Jazz Pharmaceuticals (JAZZ) says the FDA has denied its 'Citizen Petition' filed in July, addressing requirements for the submission of any Abbreviated New Drug Application of any referencing Xyrem, including the ANDA submitted by Roxane Laboratories. JAZZ claimed the ANDA woulndn't have sufficient risk controls, but the agency said the ANDA would not have demonstrated the new generic drug product would have the same labeling and conditions of use as Xyrem.
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