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Home » ENDO SUBMITS NDAS FOR OPANA TREATMENTS

ENDO SUBMITS NDAS FOR OPANA TREATMENTS

June 23, 2006

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.

KEYWORDS Drug Pipeline Alert

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