Lupin gets tentative US FDA approval for Valbenazine capsules

Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, to market a generic equivalent of Ingrezza Capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc.

Valbenazine is indicated for the treatment of tardive dyskinesia (uncontrollable movement of face, tongue, or other body parts).

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of $ 1,235 million in the US. (IQVIA MAT December 2022).