Lupin has received tentative nod from the US health regulator to market its generic brivaracetam tablets, used for treating partial-onset seizures in patients aged four and above. Lupin will manufacture the tablets at its plant located at Nagpur.
"The company (Lupin) has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets," Lupin said in a regulatory filing to the stock exchanges. The product is a generic version of UCB Biopharma SPRL's Briviact tablets, it added.
The brivaracetam tablets had estimated annual sales of USD 311 million in the United States, as per IQVIA MAT June 2021 data.
Lupin, headquartered in Mumbai, develops branded and generic formulations, biotechnology products and APIs for the domestic and overseas markets.
At 3:10 pm, Lupin shares were trading higher by 0.75 per cent at Rs 974.75 on the BSE as against the Sensex's rise of 0.4 per cent. The shares of Lupin had tumbled more than 17 per cent in the past seven days, post the announcement of June quarter numbers.