Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER
Drug Approval

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis

  • By IPP Bureau | November 23, 2025

Biocon has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received approval from the U.S Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tofacitinib Extended - Release (ER) Tablets. The company has secured final approval for 11mg strength and tentative approval for 22mg strength.

Tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitor indicated for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Ulcerative Colitis.

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