NDA 218390, held by Neurocrine. Valbenazine Tosylate.
As of Nov 14, 2026, NDA 218390 (Ingrezza Sprinkle), held by Neurocrine, was first approved by FDA on Apr 30, 2024, with 1 approved supplement and 0 published complete response letters.
INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia. - chorea associated with Huntington’s disease. INGREZZA and
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Ingrezza SprinkleEQ 40MG BASE · capsule;oral | Valbenazine Tosylate | RxReference drug |
| Ingrezza SprinkleEQ 60MG BASE · capsule;oral | Valbenazine Tosylate | RxReference drug |
| Ingrezza SprinkleEQ 80MG BASE · capsule;oral | Valbenazine Tosylate | RxReference drug |
| Apr 8, 2026 | Supplement 3Labeling · Standard review | Approved | |
| Apr 30, 2024 | 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
