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Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Application for INGREZZA® (valbenazine) Oral Granules Sprinkle Formulation
Prescription Drug User Fee Act (PDUFA) Target Action Date Set for April 30, 2024SAN DIEGO, Sept. 14, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc.
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"Prescription Drug User Fee Act (PDUFA) Target Action Date Set for April 30, 2024SAN DIEGO, Sept. 14, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) 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.\n\n \n \n \n \n \n \n\n \nThe 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.\n\"Patients with tardive dyskinesia or chorea associated with Huntington's disease can experience dysphagia that can impact their ability to swallow capsules,\" said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. \"We developed this potential new formulation of INGREZZA as an alternative administration option for those patients who have difficulty swallowing or simply prefer not to take whole capsules.\"\nINGREZZA 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. It is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers three effective dosages (40 mg, 60 mg and 80 mg) that can be adjusted by the healthcare provider based on patient response and tolerability.\nAbout Tardive Dyskinesia (TD)Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription med...