FDA accepts NDA filing for Impax's Parkinson's disease treatment
HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.
Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.
The Prescription Drug User Fee Date for a decision by the FDA is Oct. 21, Impax said.