Impax Pharmaceuticals, a division of Impax Laboratories, Inc. has resubmitted Impax’s new drug application (NDA) for Rytaryâ„¢ (IPX066) to FDA. IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson’s disease.
After discussions with FDA, the company resubmitted the NDA for Rytaryâ„¢ providing updated safety and stability information. FDA will require an inspection of manufacturing facilities involved in the production of Rytaryâ„¢ in connection with the resubmission. The FDA has designated the NDA filing for Rytaryâ„¢ as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.