Lupin gets nod for Leflunomide Tablets
6th Feb 2020

Lupin has received approval for its Leflunomide Tablets USP, 10 mg and 20 mg, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Arava Tablets, 10 mg and 20 mg, of Sanofi-Aventis. The product would be manufactured at Lupin's Pithampur (Unit 1) facility, India.

Leflunomide Tablets USP, 10 mg and 20 mg, are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide Tablets USP (RLD: Arava Tablets) had an annual sales of approximately $44 million in the U.S. (IQVIA MAT December 2019).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.