Biocon Pharma Limited, a wholly owned arm of Biocon, has received a key regulatory nod from the U.S. Food and Drug Administration (FDA) for its Tofacitinib Extended-Release Tablets. The company has secured final approval for the 11 mg strength and a tentative approval for the 22 mg version.

Tofacitinib is a Janus kinase (JAK) inhibitor used in the treatment of several autoimmune and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. With this approval, Biocon Pharma strengthens its U.S. portfolio in the specialty generics space and expands its presence in the autoimmune therapeutic segment.

The company said the approval marks another step in its efforts to bring accessible and high-quality treatments to patients in global markets.