Endo pulls FDA submission regarding specific abuse-deterrent labelling for Opana ER

Endo International announced Friday that it has decided to withdraw its marketing application concerning specific abuse-deterrent labelling for the opioid agonist Opana ER (oxymorphone) following discussions with the FDA. Sue Hall, the company's chief scientific officer, stated "we anticipate the generation of additional data and we will seek collaboration with the FDA to appropriately advance Opana ER."

The announcement came after Endo revealed in June that an FDA advisory panel meeting concerning the submission would be held in the fall of 2016, delaying the agency's decision on the drug, which was scheduled by July 29. The drugmaker indicated that it plans to continue collecting and analysing epidemiological data for Opana ER.

Endo posted sales of $44.7 million for Opana ER in the first quarter of 2016, down 4.7 percent versus the year-ago period due to generic competition. Teva's Actavis unit received FDA approval for a generic version of the drug in 2013 after the agency declined Endo's request to block the launch of the generic product. Meanwhile, Aurobindo was granted clearance to market a generic version of Endo's product earlier this year.

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