Neurocrine Biosciences, Inc. — Ingrezza FDA Review (NDA218390, ORIG 1, 2024)
Neurocrine Biosciences, Inc. · 2024 · FDA Review (openFDA) · company profile →
Report summary
Neurocrine Biosciences' Ingrezza Sprinkle (valbenazine oral granules) is recommended for approval to treat tardive dyskinesia and Huntington's disease chorea. This new formulation, designed for patients with swallowing difficulties, relies on the established efficacy and safety of the original Ingrezza capsule. A pharmacokinetic bridging study (NBI-98854-1730) demonstrated bioequivalence between the sprinkle and capsule formulations, confirming comparable pharmacokinetics and no significant food effect. The labeling for Ingrezza Sprinkle will be largely identical to the existing capsule, including all boxed warnings. This approval offers a valuable alternative for patients needing a sprinkle formulation.
Key findings — cited to the page
| Application Number | NDA 218390 | Ingrezza Sprinkle · Global · p.2 |
| PDUFA Goal Date | 04/30/2024 | Ingrezza Sprinkle · Global · p.2 |
| Review Completion Date | 04/30/2024 | Ingrezza Sprinkle · Global · p.2 |
| Recommended Regulatory Action | Approval | Ingrezza Sprinkle · Global · p.2 |
| Valbenazine original capsule approval date for TD | April 11, 2017 | Ingrezza · Global · p.10 |
| Valbenazine original capsule approval date for HC | August 18, 2023 | Ingrezza · Global · p.10 |
| NDA 209241 approval date for TD | 04/11/2017 | Ingrezza · Global · p.16 |
| NDA 209241 Supplement 020 approval date | 04/23/2021 | Ingrezza · Global · p.16 |
| NDA 218390 submission date | 06/30/2023 | Ingrezza Sprinkle · Global · p.16 |
| NDA 209241 Supplement 026 approval date for HC | 08/18/2023 | Ingrezza · Global · p.16 |
| NDA 218390 Filing Date | 08/29/2023 | Ingrezza Sprinkle · Global · p.16 |
| Application Type | Original 505(b)(1) NDA | Ingrezza Sprinkle · Global · p.2 |
Source: Neurocrine Biosciences, Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →