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(R) 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.
"We also intend to continue to vigorously defend the ongoing patent litigation as previously announced with Endo and Penwest and look forward to prevailing and bringing this important generic product to market," said Larry Hsu, Ph.D., IMPAX's president and chief executive officer.
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