Teva's AUSTEDO XR Receives FDA Approval For Movement Disorders Treatment

(RTTNews) - The U.S. Food and Drug Administration has approved AUSTEDO XR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington's disease, Teva Pharmaceutical Industries Ltd. (TEVA) said in a statement.

AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO.

AUSTEDO XR will be available in three extended-release tablet strengths - 6 mg, 12 mg, and 24 mg - and can be taken with or without food. The new tablet strengths provide an updated regimen which may result in a decreased pill count for patients compared to the twice-daily formulation.

AUSTEDO XR is expected to be available in the U.S. later this year.

Tardive dyskinesia is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.

Huntington's disease is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems.

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