Impax Pharma Resubmits NDA For RYTARY Extended-Release Capsules

(RTTNews) - Impax Pharmaceuticals, a division of Impax Laboratories Inc. (IPXL), announced the resubmission of Impax's New Drug Application or NDA for RYTARY (IPX066) to the U.S. Food and Drug Administration or FDA. IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease or PD.

After discussions with the FDA, the company said it has resubmitted the NDA for RYTARY providing updated safety and stability information. The FDA will require an inspection of manufacturing facilities involved in the production of RYTARY in connection with the resubmission. The FDA has designated the NDA filing for RYTARY as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.

RYTARY is an investigational extended-release capsule formulation of carbidopa and levodopa for the treatment of idiopathic Parkinson's disease. It is not approved or licensed anywhere in the world.

Parkinson's disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.