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FDA Approves First Drug for Tardive Dyskinesia
FDA news release; 2017 Apr 11
The US Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing. The first drug approved by the FDA for this condition, Ingrezza is manufactured by Neurocrine Biosciences, Inc., headquartered in San Diego, CA.
Indications: Ingrezza is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.
Dosage/administration: The initial dose is 40 mg once daily. After 1 week, the dose is increased to 80 mg once daily.
Adverse reactions: Ingrezza may cause serious side effects including sleepiness and heart rhythm problems (QT prolongation). Its use should be avoided in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval.
US Food and Drug Administration. FDA approves first drug to treat tardive dyskinesia. FDA Web site. April 11, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552418.htm. Accessed April 13, 2017.
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