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.
IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the U.S. and in Europe. The NDA included data from three controlled Phase III studies and two open label extensions of IPX066 in both early and advanced PD. IPX066 has been investigated in more than 1,000 subjects.