Endo fails in FDA law suit to stop generic Opana ER in USA; Mylan settles with Orion

The US District Judge Reggie Walton, of the District Court for the District of Columbia, has dismissed the case of Endo Pharmaceuticals (Nasdaq: ENDP) against the US Food and Drug Administration.

Endo Pharmaceuticals argued that the FDA failed to meet its legal obligation to determine in a timely manner whether the original formulation of Opana ER (oxymorphone hydrochloride) extended-release tablets was withdrawn from the market for reasons of safety.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, intended for the treatment of moderate to severe pain, 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 January 2, 2013. Impax Laboratories and Actavis South Atlantic are among producers of the generic Opana ER, Endo said in the complaint.