Neurocrine : FDA Accepts NDA For Ingrezza Oral Granules Sprinkle Formulation

(RTTNews) - Neurocrine Biosciences Inc. (NBIX) said Thursday that the U.S. Food and Drug Administration has accepted its New Drug Application for Ingrezza (valbenazine) oral granules, a new sprinkle formulation of Ingrezza capsules for oral administration.

The agency set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

The Ingrezza oral granules capsules (40 mg, 60 mg and 80 mg) are intended to be opened for sprinkling on soft foods prior to administration. 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.

Ingrezza is currently available as the only one-capsule, once-daily treatment option with no complex titration for adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease.

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