Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) 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 US $781 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).

The group now has 327 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.