US FDA to allow generic copies of Endo's Opana
Endo Health Solutions (Nasdaq: ENDP) announced Friday (May 10) that the US Food and Drug Administration has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals, regarding the potential approval of additional non-abuse deterrent formulations of generic oxymorphone, the active ingredient of its Opana. Endo’s shares fell 5.3% to $34.97 on the news.
Currently marketed generics of oxymorphone are from Impax Labs Teva Pharmaceuticals and Actavis.
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