> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Amneal Refiles NDA for Parkinson’s Drug
- URL: https://www.fdaweb.com/amneal-refiles-nda-for-parkinsons-drug/
- Published: 2024-02-08T12:00:00.000Z
- Updated: 2026-09-14T14:22:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156325

Amneal Pharmaceuticals has resubmitted an NDA for IPX203, a novel oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for treating Parkinson’s disease. The filing addresses issues raised in a 7/2023 complete response letter related to safety concerns, according to the company. “The resubmission package included data from a healthy volunteer study which was conducted in the fourth quarter of 2023,” it says, adding that the agency did not request any other studies.

The drug is described as a new formulation of carbidopa/levodopa that is designed to remain in the small intestine for a longer period, helping it to be consistently absorbed.