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# CRL for Amneal Parkinson’s Drug
- URL: https://www.fdaweb.com/crl-for-amneal-parkinsons-drug/
- Published: 2023-07-10T12:00:00.000Z
- Updated: 2026-09-14T18:42:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154831

FDA has issued a complete response letter for an Amneal Pharmaceuticals drug intended to help control Parkinson’s symptoms for a longer duration. The agency letter cited safety concerns, Reuters [reports](https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-amneal-pharmas-parkinsons-drug-2023-07-03/?ref=fdaweb.com).

The company said FDA requested additional data as it was not convinced of the safety of carbidopa, one of the drug’s ingredients. The letter did not identify any efficacy or manufacturing issues, Amneal said.

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.

Amneal says it will work with FDA to address the issues, Reuters says.