Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

By: IPP Bureau

Last updated : November 23, 2025 5:42 pm



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


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.

Rheumatoid Arthritis USFDA Biocon Pharma

First Published : November 23, 2025 12:00 am