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# FDA 2nd Complete Response on Parkinson’s Drug
- URL: https://www.fdaweb.com/fda-2nd-complete-response-on-parkinsons-drug/
- Published: 2024-04-08T12:00:00.000Z
- Updated: 2026-09-14T14:27:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156725

FDA has issued Supernus Pharmaceuticals a second complete response letter (CRL) on its NDA resubmission for the company’s apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (“off”episodes) in Parkinson’s disease. The letter said the submission is not ready for approval in its present form, adding that the agency requires more information about product quality and the master file for the infusion device.

Supernus says it recently submitted additional product quality data to FDA which the agency has not yet reviewed, and the master file for the device, which it plans to discuss further. “No clinical safety or efficacy issues were identified as a requirement for approval,” the company says, adding that it passed an FDA preapproval inspection in February. “We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA,” it says.

FDA issued the first CRL in 10/2022, when it requested “additional information and analysis related to the infusion device and drug product across several areas of the NDA including, but not limited to, labeling, product quality and manufacturing, device performance and risk analysis,” the company said at the time. The agency also said that before an approval could be granted, inspections were needed because they could not be completed in a timely manner due to Covid-19 travel restrictions.