NDA 209241, held by Neurocrine. Valbenazine Tosylate.
As of Nov 14, 2026, NDA 209241 (Ingrezza), held by Neurocrine, was first approved by FDA on Apr 11, 2017, with 10 approved supplements 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
| Aug 18, 2023 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Apr 23, 2021 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Apr 11, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| IngrezzaEQ 40MG BASE · capsule;oral | Valbenazine Tosylate | RxReference drug |
| IngrezzaEQ 80MG BASE · capsule;oral | Valbenazine Tosylate | RxReference drug |
| IngrezzaEQ 60MG BASE · capsule;oral | Valbenazine Tosylate | RxReference drug |
| Oct 23, 2026 | Supplement 34Labeling · Standard review | Approved | |
| Feb 4, 2025 | Supplement 29Labeling · Standard review | Approved | |
| Nov 22, 2024 | Supplement 28Labeling · Standard review | Approved | |
| Aug 18, 2023 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2022 | Supplement 24Manufacturing · Standard review | Approved | |
| Apr 23, 2021 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Apr 9, 2020 | Supplement 16Labeling · Standard review | Approved | |
| Jul 15, 2019 | Supplement 12Labeling | Approved | |
| Jan 10, 2019 | Supplement 6Manufacturing | Approved | None posted |
| Aug 10, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Apr 11, 2017 | Original applicationNew molecular entity · Priority 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
