Lupin Limited announced the launch of Leflunomide Tablets USP, 10 mg and 20 mg, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. The product would be manufactured at Lupin’s Pithampur (Unit I) facility in India.
Leflunomide Tablets USP, 10 mg and 20 mg, is the generic equivalent of Arava® Tablets, 10 mg and 20 mg, of Sanofi-Aventis U.S. LLC., and is indicated for the treatment of adults with active rheumatoid arthritis (RA).
Leflunomide Tablets USP (RLD: Arava®) had an annual sales of approximately USD 42 million in the U.S. (IQVIA MAT June 2020).