India, June 10 -- Concord Biotech Limited 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.
Tofacitinib is indicated for the treatment of several autoimmune and inflammatory conditions, including moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), and polyarticular course juvenile idiopathic arthritis (pcJIA).
According to industry estimates, the combined U.S. market for Tofacitinib Tablets in both strengths is valued at approximately US$ 500 million, offering a significant commercial opportunity for the company.
The approva...