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Zydus gets tentative USFDA approval for Valbenazine capsules

Valbenazine capsules are indicated for the treatment of adults with tardive dyskinesia. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
  • Updated On Oct 17, 2022 at 02:08 PM IST
Read by: 100 Industry Professionals
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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.

Valbenazine capsules had annual sales of USD 781mn in the United States according to IQVIA MAT Aug 2022 data.
  • Published On Oct 17, 2022 at 02:08 PM IST
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