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Endo Health Solutions Offers Comment on Dismissal of Suit Against FDA

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Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that U.S. District Judge Reggie B. Walton, of the U.S. District Court for the District of Columbia, dismissed the case of Endo's subsidiary, Endo Pharmaceuticals Inc., against the U.S. Food and Drug Administration (FDA).  Endo Pharmaceuticals argued that FDA failed to meet its legal obligation to determine in a timely manner whether the original formulation of OPANA ER was withdrawn from the market for reasons of safety.  The judge ruled against Endo, noting that he believes the FDA has not unduly delayed making a determination on the matter.  The FDA stated that it intends to make its determination by May 2013. 

Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012. The ruling by the court now allows for a generic non-tamper resistant version to enter the market on Jan. 2, 2013. 

Posted-In: News FDA Legal


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