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Ingrezza Approval History

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

Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor for the treatment of tardive dyskinesia.

Development History and FDA Approval Process for Ingrezza

Apr 11, 2017Approval Neurocrine Announces FDA Approval of Ingrezza (valbenazine) as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)
Mar 21, 2017Neurocrine Announces American Journal of Psychiatry Publication of Positive Results from Kinect 3 Phase III Study of Ingrezza (valbenazine) for the Treatment of Tardive Dyskinesia
Jan 17, 2017Neurocrine Announces Completion of Phase II Clinical Study of VMAT2 Inhibitor Ingrezza (valbenazine) in Adults with Tourette Syndrome
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

Further information

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