Endo Pharmaceuticals has announced
that the FDA has granted final approval for the company's new drug applications
(NDAs) for its extended-release and immediate-release formulations of oxymorphone
hydrochloride. These products are now known under the trade names Opana ER tablets
and Opana tablets.
Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. This is the first time oxymorphone will be available in an oral, extended-release formulation. Opana ER will be available in 5 mg, 10 mg, 20 mg and 40 mg tablets. Opana (the immediate-release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate and will be available in 5mg and 10mg tablets.