Zydus Lifesciences gets FDA tentative approval for Valbenazine Capsules

Zydus Lifesciences (previously called Cadila Healthcare) said that its subsidiary Zydus Worldwide DMCC has been given tentative approval from the US Food and Drug Administration (FDA) for Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg.

The product is a generic of Neurocrine Biosciences‘ Ingrezza, which was approved by the FDA in 2017.

According to Zydus Lifesciences, Valbenazine Capsules are approved for their use in the treatment of adults having tardive dyskinesia.

The Indian pharma company will manufacture the drug at its formulation manufacturing plant in Ahmedabad SEZ.

Zydus Lifesciences gets FDA tentative approval for Valbenazine Capsules. Photo courtesy of Zydus Cadila.

As per IQVIA MAT Aug 2022, Valbenazine Capsules had annual sales of $781 million in the US.

Zydus Lifesciences said that it currently has 327 approvals and to date filed more than 428 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.