IMPAX Laboratories, Inc. Announces FDA Acceptance of ANDA for Generic Version of Opana(R) ER

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that its Abbreviated New Drug Application (ANDA) for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana® ER, has been deemed acceptable for filing by the U. S. Food and Drug Administration (FDA) as of November 23, 2007. Despite the acceptance, the Company continues to believe that its ANDA as originally filed met all the requirements for acceptance and thus will continue to pursue its administrative remedies with the FDA to reinstate its original filing date of June 29, 2007.

MORE ON THIS TOPIC