FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson’s Disease
2/23/2012 6:16:33 AM
HAYWARD, Calif.--(BUSINESS WIRE)--Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson’s disease (PD) submitted to the Agency on December 21, 2011. IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD). The Prescription Drug User Fee Date (PDUFA) for a decision by the FDA is October 21, 2012. IPX066 has been licensed to GlaxoSmithKline (GSK) for countries outside the U.S. and Taiwan for development and marketing.