Lupin Receives Approval from U.S. FDA for Valbenazine Capsules

Telugu super news, April 8, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Valbenazine Capsules, 40 mg and 80 mg, to market a generic equivalent of Ingrezza® Capsules, 40 mg and 80 mg, of Neurocrine Biosciences, Inc. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.  The product will be manufactured at Lupin’s Nagpur facility in India.

Valbenazine Capsules, 40 mg and 80 mg (RLD Ingrezza®) had estimated annual sales of USD 1621 million in the U.S. (IQVIA MAT February 2024).