Zydus Lifesciences arm secures USFDA nod for tardive dyskinesia drug Valbenazine

Ahmedabad: Zydus Lifesciences Limited's (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 (USRLD: Ingrezza).

Valbenazine Capsules are indicated for the treatment of adults with tardive dyskinesia.

Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips, and tongue, such as grimacing, sticking out the tongue, and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing.

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). 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.

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Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.

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