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FDAnews Drug Daily Bulletin

ENDO'S NDAS FOR PAIN DRUGS GRANTED FINAL APPROVAL

July 5, 2006

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.