Impax Pharmaceuticals Announces Extension of RYTARY FDA Review Date To January 9, 2015

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY™ (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015. The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to its submission of responses to the July 26, 2014 Form 483 observations at the Taiwan facility. The FDA notified the Company that such amendment constituted a major amendment. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has extended the PDUFA date to review the information. No additional information was requested by the Agency."As this was one of the possible outcomes to our data submission, our focus will continue to be on supporting the FDA review of the RYTARY NDA, preparing the commercial programs and planning to bring this new treatment option to patients who are suffering from Parkinson's disease," said Fred Wilkinson, president and chief executive officer of Impax Laboratories, Inc. "In addition, we are progressing towards our goal of filing the Marketing Authorization Application with the European Medical Agency later this year."