USFDA gives tentative approval for Valbenazine capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

Ahmedabad: Zydus Lifesciences Limited’s subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Valbenazine capsules USP 40 mg, 60 mg, and 80 mg.

Valbenazine capsules are indicated for the treatment of adults with tardive dyskinesia (movements in the face, tongue, or other body parts that cannot be controlled).

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

According to IQVIA MAT Aug 2022 data, Valbenazine capsules had annual sales of USD 781 million in the United States.

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