US FDA to allow generic copies of Endo's Opana

13 May 2013

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.

Endo presented the FDA with data collected from an ongoing epidemiology study which indicate that per 100,000 prescriptions dispensed, the past 30-day abuse rate of crush-resistant Opana ER was 79% lower than the abuse rate of generic versions of extended-release oxymorphone that were on the market in 2012. Endo, through its Citizen Petition, requested that the FDA:

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