Supernus announces SPN-830 NDA accepted for review by FDA

Supernus Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has acknowledged the resubmission of the new drug application, NDA, for its apomorphine infusion device, SPN-830, for the continuous treatment of motor fluctuations in Parkinson’s disease. The resubmission is now considered filed, with a user fee goal date of April 5, 2024. “We are pleased with the FDA’s acceptance of our NDA resubmission for SPN-830 and look forward to continuing to work with them during their review,” said Jack Khattar, President and CEO of Supernus. “SPN-830 is an important product candidate which, if approved by the FDA, represents a novel and less invasive treatment option for PD patients.”