Treats attention-deficit/hyperactivity disorder (ADHD). NDA 218145, held by Otsuka Pharmaceutical Co Ltd. Centanafadine Hydrochloride.
As of Nov 14, 2026, NDA 218145 (Simtriyo), held by Otsuka Pharmaceutical Co Ltd, was first approved by FDA on Jul 24, 2026, with 0 approved supplements and 0 published complete response letters.
SIMTRIYO is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older weighing at least 20 kg. Limitations of Use The use of SIMTRIYO is not recommended in pediatric patients: Younger than 6 years of age because this pediatric subpopulation had a higher incidence of weight loss than pediatric patients 6 years of age and older. Weighing less than 20 kg because of a lack of data for this subpopulation and the risk of weight loss.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simtriyo280MG · capsule, extended release | Centanafadine Hydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
