Actavis' generic version of Opana ER wins FDA approval

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic opioid painkiller made by Actavis, the drug maker said.

Actavis announced the approval of oxymorphone hydrochloride extended-release tablets in the 5-mg, 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic of Endo Health Solutions' Opana ER, but is based on a non-crush resistant version that was withdrawn from the market last year. An FDA rule finalized earlier this year allows for generic versions of the earlier formulation of Opana ER, though Endo only makes the crush-resistant formulation.

Opana ER tablets had sales of about $461 million during the 12-month period that ended in May, according to IMS Health. Actavis already markets the 7.5-mg and 15-mg versions.