Impax Laboratories (Netherlands) B.V., a wholly owned subsidiary of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has submitted a Marketing Authorization Application for IPX066 to the European Medicines Agency (EMA). IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease.
"The submission of the EMA Marketing Authorization Application for IPX066 brings us one step closer to providing this new treatment option to patients who are suffering from Parkinson's disease," said Fred Wilkinson, president and chief executive officer of Impax. "We look forward to working with the EMA as it conducts its review of IPX066."
The EMA filings follow the New Drug Application resubmission of IPX066 (brand name RYTARY™ in the United States) to the U.S. Food and Drug Administration (FDA) which was announced on April 11, 2014. The Prescription Drug User Fee Act (PDUFA) date for a decision by the FDA is January 9, 2015. The company has initiated a process to find a partner to commercialize IPX066 for territories outside the United States.