Impax Laboratories, Inc.'s (IPXL) branded products division, Impax Pharmaceuticals, said the U.S. Food and Drug Administration has accepted for filing the company's New Drug Application, or NDA, for IPX066 for the treatment of idiopathic Parkinson's disease submitted to the Agency on December 21, 2011. The Prescription Drug User Fee Date for a decision by the FDA is October 21, 2012.
IPX066 is a patented extended release capsule formulation of carbidopa-levodopa.
The NDA included data from three controlled Phase III studies and two open label extensions of IPX066 in both early and advanced Parkinson's disease.
by RTT Staff Writer
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