Posted by Michael Wonder on 09 Feb 2021
Supernus resubmits new drug application for SPN-812 for the treatment of ADHD in paediatric patients
8 February 2021 - Supernus Pharmaceuticals today announced it has resubmitted its ew drug application for SPN-812 for the treatment of ADHD in paediatric patients.
The U.S. FDA issued a complete response letter regarding the new drug application in November 2020 indicating that the review cycle for the application was incomplete and that the application was not ready for approval in its present form.
Supernus and the FDA held a Type A meeting in January 2021 to discuss the complete response letter and the requirements for the resubmission.
