Lupin Gets US FDA Nod To Market Generic Medication
The company has received approval from the U.S. Food and Drug Administration to market Valbenazine Capsules in strength of 40 mg and 80 mg.
Drug firm Lupin on Monday said it has received approval from the U.S. health regulator to market a generic medication to treat involuntary movements caused by tardive dyskinesia.
The company has received approval from the U.S. Food and Drug Administration 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 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 $1,621 million in the U.S.
Shares of the company on Monday ended 0.91% up at Rs 1,612.65 apiece on the BSE.