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FDA Requires More Time To Review Oxymorphone NDAs

CHADDS FORD, Pa., March 31 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals Holdings Inc. today announced the outcome of its recent meeting with the U.S. Food and Drug Administration (FDA) to review its proposed strategy for addressing the questions and issues raised in the approvable letters received in October 2003 regarding the New Drug Applications (NDAs) for its oxymorphone extended-release tablets (oxymorphone ER) and immediate- release tablets (oxymorphone IR). As previously disclosed, the FDA requested that Endo address certain questions and provide additional clarification and information, including some form of additional clinical trials to further confirm the safety and efficacy of these products.

While the FDA concurred with Endo's approach on all other issues with regard to oxymorphone ER, the status of the FDA's request for additional clinical trials for oxymorphone ER was not resolved. The FDA indicated more time was required to adequately review Endo's additional analyses of certain data from the oxymorphone ER clinical trials and committed to respond to Endo as soon as possible, which Endo believes will be during the second quarter of 2004.

In regard to oxymorphone IR, the FDA indicated that more safety and efficacy information from patients receiving repeated doses of the drug will be required. Endo will conduct a short-term repeat-dose study with oxymorphone IR to resolve this question, which will be initiated following agreement on the study design with the agency.

"We are pleased to have made further progress in responding to the questions raised in the approvable letters, and we are confident that our next meeting with the FDA will allow us to develop a definitive timeline regarding the next steps needed to achieve final approval and launch of oxymorphone ER and IR," said Carol A. Ammon, chairman and chief executive officer.

Source: Endo Pharmaceuticals

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