FDA Denies Jazz Pharma (JAZZ) Citizen Petition Over NDA Filings

December 13, 2012 5:33 PM EST Send to a Friend
On December 13, 2012, the U.S. Food & Drug Administration (the “FDA”) denied the Citizen Petition filed by Jazz Pharmaceuticals, Inc., a wholly owned subsidiary of Jazz Pharmaceuticals plc (Nasdaq: JAZZ), on July 10, 2012 (the “July 2012 Citizen Petition”). The July 2012 Citizen Petition addressed the requirements for submission of any abbreviated new drug application, or ANDA, referencing Xyrem and asked the FDA to rescind the acceptance of any previously-accepted ANDA referencing Xyrem, including the ANDA submitted by Roxane Laboratories, Inc. (“Roxane”), that did not contain a proposed risk management system at the time it was accepted for review, because such ANDA would not have demonstrated, as required by law, that the new generic drug product would have the same labeling and conditions of use as Xyrem. The July 2012 Citizen Petition further requested that the FDA (i) not accept for review any ANDA referencing Xyrem that does not contain, at the time of its submission, a proposed risk management system sufficient to demonstrate that the new generic drug product has the same labeling and conditions of use as Xyrem; and (ii) determine that if any sponsor, including Roxane, of an ANDA referencing Xyrem that did not contain, at the time it was accepted for review, a proposed risk management system later submits, or resubmits, an ANDA that contains a proposed risk management system sufficient to demonstrate that the new generic drug product would have the same labeling and conditions of use of Xyrem, then such ANDA should not be approved for a period of up to thirty months beginning on the date the Company receives notice of any Paragraph IV certifications contained in such new ANDA, to the extent that the Company avails itself of its right to initiate a patent infringement action based on such notice.

The Company is evaluating the FDA’s response to the July 2012 Citizen Petition and potential further actions that the Company may take with respect to the issues raised in the petition. The July 2012 Citizen Petition was directed to the filing requirements for an ANDA referencing Xyrem and does not address all of the requirements for approval of any such ANDA, or the effect of other provisions of applicable FDA regulations. The July 2012 Citizen Petition and the FDA’s response are also independent of protections provided by the Company’s intellectual property and the impact of ongoing and potential additional litigation related to currently filed or potential future ANDAs referencing Xyrem.


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