Biocon Pharma Limited, a subsidiary of Biocon, has received approval from the U.S. Food and Drug Administration (FDA) for its ANDA for Tofacitinib Extended-Release Tablets. The approval includes final approval for the 11mg strength and tentative approval for the 22mg strength. Tofacitinib is a Janus kinase (JAK) inhibitor used to treat Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis. The approval is expected to strengthen Biocon’s portfolio.
FDA Approval Received
Biocon Pharma Limited has secured approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) concerning Tofacitinib Extended-Release Tablets. The announcement was made on November 19, 2025.
Details of the Approval
The U.S. FDA has granted final approval for the 11mg strength of Tofacitinib Extended-Release Tablets. Simultaneously, the agency has issued tentative approval for the 22mg strength of the same medication. Tofacitinib is classified as a Janus kinase (JAK) inhibitor. This inhibitor is prescribed for conditions such as Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis.
Strategic Implications for Biocon
This approval is expected to positively impact Biocon’s business strategy by enhancing its product offerings in the complex drug market. The company aims to leverage this approval to further strengthen its integrated pharmaceutical portfolio.
Source: BSE