Impax Labs Launches Oxymorphone Hydrochloride ER Tablets

Impax Laboratories, Inc.

today announced that it is commencing shipment of Oxymorphone Hydrochloride Extended-Release Tablets, through Global Pharmaceuticals, Impax's generics division. In June 2010, Impax reached agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals (collectively Endo) to settle U.S. patent litigation with regard to the production and sale of its Oxymorphone Hydrochloride Extended-Release Tablets approved by the U.S. Food and Drug Administration (FDA) as therapeutically equivalent to the original formulation of OPANA® ER. Under the terms of the settlement, Endo agreed to grant Impax a license to sell Impax's approved product on January 1, 2013. As a company whose mission is to provide high quality, lower-cost prescription drugs, Impax is actively participating in efforts to support prescriber and patient education of this product through the FDA-approved Risk Evaluation and Mitigation Strategy (REMS). Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.