Impax Pharmaceuticals, a division of Impax Laboratories Inc., announced the resubmission of Impax’s New Drug Application (NDA) for Rytary (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 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 Rytary as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.
“We are excited to resubmit the updated NDA for Rytary and remain enthusiastic about the potential commercial opportunity for the product,” said Michael Nestor, president of Impax Pharmaceuticals.
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. Results from the phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
Parkinson’s disease is a chronic neurodegenerative movement disorder affecting over three million people in the U.S., Europe, and Japan.
Date: April 11, 2014
Source: Impax Laboratories
Filed Under: Drug Discovery