FDA CRL - NeuroDerm, Ltd.

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to NeuroDerm, Ltd. regarding its New Drug Application (NDA 218317) for a carbidopa and levodopa injection. The agency determined that the application cannot be approved in its current form due to significant manufacturing and safety data requirements. A primary concern involves a manufacturing facility that failed to meet Current Good Manufacturing Practice (CGMP) standards during a previous inspection. The FDA requires the facility to resolve all deficiencies noted in the inspection report (Form 483), which may necessitate a re-inspection and a Pre-Approval Inspection prior to any potential approval. Additionally, NeuroDerm must provide a comprehensive safety update as required by 21 CFR 314.50. This update must include new data from all nonclinical and clinical trials, detailed reports on adverse events, and a summary of worldwide safety experience. While the product's proposed proprietary name was found conditionally acceptable, the FDA has reserved final comments on the drug's labeling until these other deficiencies are addressed. Under the regulatory framework of 21 CFR 314.110, NeuroDerm has one year to provide a complete resubmission addressing all identified issues or request an extension. Failure to respond may lead the FDA to consider the application withdrawn.