Biocon Pharma Receives U.S. FDA Approval for Tofacitinib Extended-Release Tablets

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Ltd, has received approval from the U.S Food and Drug Administration (U.S. FDA) for its ANDA for Tofacitinib Extended-Release Tablets. The approval is for the 11mg strength and a tentative approval for the 22mg strength. Tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitor indicated for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Ulcerative Colitis. This approval will further strengthen Biocon’s portfolio of vertically integrated, complex drug products.