DAYTON, N.J. — Aurobindo Pharma Ltd. has gained approval from the Food and Drug Administration for oxymorphone HCl tablets 5 mg and 10 mg, an opioid painkiller.
Aurobindo said Thursday that its oxymorphone tablet product is a generic version of Opana tablets (5 mg and 10 mg) from Endo Pharmaceuticals Inc.
Oxymorphone tablets (5 mg and 10 mg) are indicated for the treatment of moderate to severe acute pain where the use of an opioid is appropriate.
For the 12 months through March, oxymorphone HCl tablets totaled U.S. sales of $103.1 million, according to IMS Health data reported by Aurobindo.
