FDAnews Drug Daily Bulletin

ENDO'S NDAS FOR PAIN DRUGS GRANTED FINAL APPROVAL

July 5, 2006
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Endo Pharmaceuticals has reported that the FDA has granted final approval of the company's new drug applications for its extended-release and immediate-release formulations of oxymorphone hydrochloride. The products will be marketed as Opana ER tablets and Opana tablets.

Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous opioid treatment for an extended period of time. Opana (the immediate-release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate.

Combined net sales of Opana ER and Opana are expected to be approximately $20 to $30 million in 2006, said Endo.