Impax receives tentative approval for generic Opana ER

HAYWARD, Calif. The Food and Drug Administration has given tentative approval to an Impax Labs drug for treating pain, Impax said.

Impax announced the tentative approval of oxymorphone hydrochloride tablets in the 5-, 7.5-, 10-, 15-, 20-, 30- and 40-mg strengths.

The drug is a generic version of Endo Pharmaceuticals’ Opana ER, which had sales of $241 million during the 12-month period ended in March, according to Wolters Kluwer Health.

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