Impax Laboratories division Impax Pharmaceuticals has resubmitted its new drug application (NDA) for Rytary (IPX066) to the US Food and Drug Administration (FDA) for treatment of patients with Parkinson’s disease (PD).
PD is a chronic neurodegenerative movement disorder that affects more than three million people in the US, Europe and Japan.
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IPX066 is a patented extended-release capsule formulation of carbidopa and levodopa, an investigational drug, indicated to treat idiopathic PD.
The company has provided updated safety and stability information in the resubmitted NDA for Rytary.
According to the company, FDA will inspect the manufacturing facilities involved in the production of Rytary in connection with the resubmission.
In addition, the FDA has designated the NDA filing of Rytary as a Class 2 resubmission for review purposes and has 14 days to officially accept the resubmission.
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By GlobalDataResults from the Phase III trials of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) were useful for the NDA resubmission.
Rytary is currently not approved or licensed anywhere in the world.
Impax Laboratories is applying its formulation expertise and drug delivery technology in the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products.
