Lupin gets USFDA tentative approval for Valbenazine Capsules

The United States Food and Drug Administration (US FDA) has tentatively approved Lupin’s Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, to market a generic equivalent of Neurocrine Biosciences, Inc.’s Ingrezza® Capsules, 40 mg, 60 mg, and 80 mg. In the United States, Valbenazine Capsules (RLD Ingrezza®) had an estimated annual sales of USD 1,235 million (IQVIA MAT December 2022).