Lupin receives tentative approval from USFDA for Valbenazine capsules

Lupin receives tentative approval from USFDA for Valbenazine capsules

By: IPP Bureau

Last updated : March 28, 2023 10:20 am



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


Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) 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 Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Lupin USFDA

First Published : March 28, 2023 12:00 am