Ingrezza Oral Granule (valbenazine oral granules sprinkle capsule) / Neurocrine Biosciences - LARVOL DELTA

Action Date: 04/08/2026 | New Drug Application (NDA): 218390 (FDA) - "This NDA provides for the use of Ingrezza Sprinkle for treatment of tardive dyskinesia and chorea associated with Huntington’s disease...We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling...Based on the stability data submitted to date, the expiry dating period for Ingrezza Sprinkle capsules shall be a 24-month shelf life when stored at 20 to 25 °C."

FDA approval • Huntington's Disease • Movement Disorders

Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA SPRINKLE (valbenazine) Capsules (PRNewswire) - "Neurocrine Biosciences, Inc...today announced the U.S. Food and Drug Administration has approved INGREZZA SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease....The U.S. Food and Drug Administration (FDA) approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared to INGREZZA capsules."

NDA • Huntington's Disease • Movement Disorders

Year in Review: Huntington's Disease: New drug approved for chorea, and more insights about understanding the disease this year (MedPageToday) - "With scores in the PROOF-HD trial averaging about 9.9 at enrollment in the two arms, both groups saw declines of 1 point during the study, reported Andrew Feigin, MD....Change from baseline in UHDRS-TFC score was the trial's primary endpoint....Further analyses are forthcoming, Feigin said. An open-label extension is also underway, which includes nearly all of the 437 patients who were still in the trial at week 65."

Media quote

Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Application for INGREZZA (valbenazine) Oral Granules Sprinkle Formulation (PRNewswire) - "Neurocrine Biosciences, Inc...today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for INGREZZA® (valbenazine) oral granules, a new sprinkle formulation of INGREZZA® (valbenazine) capsules for oral administration. The agency set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024....The NDA filing included chemistry, manufacturing, and controls (CMC) information and data demonstrating the bioequivalence and tolerability of the INGREZZA oral granule sprinkle capsules compared to the currently approved INGREZZA capsules."

NDA • PDUFA date • Genetic Disorders • Huntington's Disease • Movement Disorders