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# Supernus Resubmits NDA for ADHD Drug
- URL: https://www.fdaweb.com/supernus-resubmits-nda-for-adhd-drug/
- Published: 2021-02-08T12:00:00.000Z
- Updated: 2026-09-14T16:45:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148614

Supernus Pharmaceuticals has resubmitted its NDA for SPN-812 for treating attention deficit/hyperactivity disorder (ADHD) in pediatric patients. In 11/2020, FDA issued a complete response letter, citing Supernus’ in-house laboratory that conducts analytical testing, which recently moved to a new location. In the NDA resubmission Supernus says it removed reference to its in-house laboratory and addressed other CRL issues. The company expects the agency will classify the resubmission as Class I (two-month review) or Class II (six-month review).

Meanwhile, in 12/2020, Supernus announced positive results from a Phase 3 study for SPN-812 in adults with ADHD. It plans to submit a supplemental NDA to the agency for treating this patient population in the second half of this year, assuming approval for pediatric-use submission.