Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 215401, held by Noven Pharms Inc. Dextroamphetamine.
As of Nov 13, 2026, NDA 215401 (Xelstrym), held by Noven Pharms Inc, was first approved by FDA on Mar 22, 2022, with 5 approved supplements and 0 published complete response letters.
XELSTRYM is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of XELSTRYM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xelstrym4.5MG/9HR · system;transdermal | Dextroamphetamine | RxReference drug |
| Xelstrym9MG/9HR · system;transdermal | Dextroamphetamine | RxReference drug |
| Xelstrym13.5MG/9HR · system;transdermal | Dextroamphetamine | RxReference drug |
| Xelstrym18MG/9HR · system;transdermal | Dextroamphetamine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2026 | Supplement 16Labeling · Standard review | Approved | |
| Sep 23, 2025 | Supplement 15Labeling · Standard review | Approved | |
| Nov 29, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Oct 13, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Aug 16, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Mar 22, 2022 | Original applicationNew dosage form · Standard review | Approved |
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
