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Ingrezza FDA Approval History

FDA Approved: Yes (First approved April 11, 2017)
Brand name: Ingrezza
Generic name: valbenazine
Dosage form: Capsules and Sprinkle Capsules
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia, Huntington's Disease

Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease.

Development timeline for Ingrezza

DateArticle
Apr 30, 2024Approval Neurocrine Biosciences Announces U.S. FDA Approval of Ingrezza Sprinkle (valbenazine) Capsules
Aug 29, 2023New INGREZZA Capsules Data Demonstrates Early and Sustained Improvements in Chorea Associated With Huntington's Disease
Aug 18, 2023Approval Neurocrine Biosciences Announces FDA Approval of Ingrezza (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease
Apr 11, 2017Approval Neurocrine Announces FDA Approval of Ingrezza (valbenazine) as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)
Jan  5, 2017Neurocrine Provides Update on FDA Advisory Committee for Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia
Nov 29, 2016Neurocrine Announces FDA Advisory Committee Meeting to Review Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia
Oct 11, 2016Neurocrine Announces Ingrezza (valbenazine) NDA for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by FDA
Aug 31, 2016Neurocrine Announces FDA Conditional Acceptance of Proprietary Name Ingrezza for VMAT2 Inhibitor Valbenazine
Aug 29, 2016Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia

See also

Ingrezza (valbenazine) Consumer information

Further information

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