Dayton, N.J. — Aurobindo Pharma on Thursday announced that it had received final approval from the Food and Drug Administration for its generic Opana (oxymorphone HCl) tablets. The drug is indicated to help relieve moderate to severe pain in patients whose doctors have deemed the use of an opioid appropriate.
The drug will be available in 5- and 10-mg dosage strengths and IMS Health has estimated it market size to be about $103.1 million for the 12 months ended March 2016.