Zydus gets tentative approval for Valbenazine caps

 

Mumbai, Oct 17: Zydus Lifesciences said its subsidiary Zydus Worldwide DMCC has received tentative approval from the US 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 data (IQVIA MAT Aug 2022). (UNI)