Actavis receives FDA approval for Opana ER tablets

Jul 15 2013

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

Actavis' 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generic equivalent to the previously marketed formulation of Endo Health Solutions' Opana^® ER, which was voluntarily withdrawn from sale in 2012.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 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.

Opana^® ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time. For the 12 months ending May 31, 2013, Opana^® ER tablets had total U.S. sales of approximately $461 million, according to IMS Health data.