Impax re-files Rytary at FDA for Parkinsons Disease

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. has announced the resubmission of Impax's New Drug Application (NDA) for Rytary (IPX 066) to the FDA. IPX 066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's Disease (PD).

After discussions with the FDA, the Company 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 Rytart as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.