Lupin Gets USFDA Nod for Generic Tardive Dyskinesia Drug

New Delhi, Apr 8 (PTI) Drug firm Lupin on Monday said it has received approval from the US health regulator to market a generic medication to treat involuntary movements caused by tardive dyskinesia.

The company has received approval from the US Food and Drug Administration (USFDA) to market Valbenazine Capsules in strength of 40 mg and 80 mg, the Mumbai-based drug firm said in a statement.

The company's product is a generic equivalent of Neurocrine Biosciences, Inc's Ingrezza Capsules, it added.

Lupin is one of the first abbreviated new drug application (ANDA) applicants and is eligible for 180 days of shared generic exclusivity, the company said.

As per the IQVIA MAT data, Valbenazine Capsules, 40 mg and 80 mg had estimated annual sales of USD 1,621 million in the US.

Shares of the company on Monday ended 0.91 per cent up at Rs 1,612.65 apiece on the BSE.