Concord Biotech Gets USFDA Nod for Tofacitinib Tablets

Concord Biotech Ltd has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tofacitinib Tablets in 5 mg and 10 mg strengths. These tablets are indicated for treating various autoimmune conditions including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The U.S. market for Tofacitinib Tablets is estimated at approximately US$ 500 million. This approval is expected to strengthen Concord Biotech's position in the U.S. market and support its long-term growth strategy.