Lupin receives USFDA nod for Leflunomide tablets

Pharma major-Lupin Limited announced, after the trading hours on Wednesday, that it has received approval from the United States Food and Drug Administration (USFDA) for its Leflunomide tablets USP, 10 mg and 20 mg. The drug is used for treating adults with active rheumatoid arthritis.

The product will be manufactured at Lupin's Pithampur (Unit 1) facility to market a generic equivalent of Arava tablets, 10 and 20 mg of Sanofi-Aventis, a French multinational pharma company. As per Quintiles and IMS Health's (IQVIAs) moving annual total for December 2019, Leflunomide tablets had an annual sale of approximately US$ 44 million in the US.

Lupin, the twelfth-largest company by market capitalisation, is considered to be a significant player in the cardiovascular, diabetology, asthma, pediatric, Anti-TB and so on.

At 9.30 am on Thursday, the stock is trading at Rs 727.80, up by 0.75 per cent or Rs 5.45 per share. The 52-week high is recorded at Rs 882.15 and the 52-week low is Rs 646.20 on BSE.