The U.S. Food and Drug Administration (FDA) has given its stamp of approval for INGREZZA Sprinkle (valbenazine) capsules, according to a statement from Neurocrine Biosciences Inc. This new formulation of oral granules is a variant of the current INGREZZA (valbenazine) capsules and is used in the treatment of adults suffering from tardive dyskinesia and chorea, both of which are linked to Huntington's disease.
INGREZZA SPRINKLE serves as an additional administration option aimed to help those who have difficulty swallowing or experience dysphagia.
The FDA's approval is grounded on comprehensive information relating to chemistry, manufacturing, and controls. Additionally, data demonstrating the bioequivalence and tolerability of INGREZZA Sprinkle compared to the original INGREZZA capsules are also taken into account.
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