NDA 219847, held by Azurity. Lisdexamfetamine Dimesylate.
As of Nov 13, 2026, NDA 219847 (Arynta), held by Azurity, was first approved by FDA on Jun 16, 2025, with 1 approved supplement and 0 published complete response letters.
ARYNTA is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults. Limitations of Use: The use of ARYNTA 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. ARYNTA is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arynta10MG/ML · solution;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Jun 16, 2025 | 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
