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Actavis Receives FDA Approval For Generic Opana® ER

Actavis, Inc. (ACT) announced that it has received approval from the U.S. Food and Drug Administration or FDA on its Abbreviated New Drug Application or ANDA for Oxymorphone Hydrochloride Extended-release Tablets, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg.

Actavis said its ANDA product is the generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana ER, which was voluntarily withdrawn from sale in 2012.

Actavis stated that it previously received approval for, and is currently marketing, Oxymorphone Hydrochloride Extended-release Tablets 7.5 mg and 15 mg.

The company is currently defending ongoing patent litigation initiated by Endo concerning the 7.5 mg and 15 mg Tablets, and is still evaluating launch plans for the additional dosage strengths at this time.

by RTT Staff Writer

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