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news.US-based Impax Pharmaceuticals, a division of Impax Laboratories, has resubmitted its new drug application (NDA) for Rytary (IPX066) to the US Food and Drug Administration (FDA), for the symptomatic treatment of Parkinson's disease (PD).
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IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug.
In the resubmitted NDA, the company has provided updated safety and stability information.
The company said that FDA will need an inspection of manufacturing facilities involved in the production of Rytary in connection with the resubmission.
FDA has designated Rytary’s NDA filing as a Class 2 resubmission for review purposes and has 14 days to officially accept the resubmission.
Impax Pharmaceuticals president Michael Nestor said, "We are excited to resubmit the updated NDA for RYTARY and remain enthusiastic about the potential commercial opportunity for the product."
Rytary is not approved or licensed anywhere in the world and the NDA is based on results from the Phase III trials of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD).
PD is a chronic neurodegenerative movement disorder that affects more than three million people in the US, Europe and Japan.
Image: Impax has provided updated safety and stability information in the resubmitted NDA for Rytary extended-release capsules. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net