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PARSIPPANY, N.J. — Actavis Inc. has received approval from the Food and Drug Administration for new dosages of oxymorphone hydrochloride extended-release tablets, an opioid painkiller.
The company said Friday that its oxymorphone hydrochloride ER product will be available in strengths of 5 mg, 10 mg, 20 mg, 30 mg and 40 mg.
The product is the generic equivalent to a previously marketed formulation of Endo Health Solutions’ Opana ER, which was voluntarily withdrawn from the market in 2012, according to Actavis.
Actavis said it previously received approval for and is currently marketing oxymorphone hydrochloride ER tablets in dosages of 7.5 mg and 15 mg. The company added that it’s defending ongoing patent litigation initiated by Endo regarding the 7.5 mg and 15 mg tablets and is still evaluating launch plans for the more dosage strengths.
Opana ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring around-the-clock opioid treatment for an extended period of time. For the 12 months ended May 31, Opana ER tablets had total U.S. sales of about $461 million, according to IMS Health data cited by Actavis.
