Posted by Michael Wonder on 09 Apr 2024
Supernus provides regulatory update for SPN-830
8 April 2024 - Supernus Pharmaceuticals today announced a regulatory update for SPN-830.
The FDA has issued a complete response letter in response to the Company’s new drug application for SPN-830. The complete response letter indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form.
