FDA approves Aurobindo Pharma's tofacitinib 5 mg and 10 mg
Aurobindo Pharma just got the green light from the US Food and Drug Administration (FDA) to make and sell tofacitinib tablets in 5 mg and 10 mg doses.
This medication helps adults dealing with tough cases of rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis, especially when standard treatments don't work.
Production kicks off at its APL Healthcare unit IV, and the launch is happening right away.
Aurobindo Pharma reaches 586 ANDA approvals
The US market for these tablets is pretty big, about $494 million for the 12 months ending April 2026.
With this approval, Aurobindo now has 586 ANDA approvals from the FDA, including 561 final approvals and 25 tentative approvals.
Plus, it has just opened TheraNym near Hyderabad for biologics manufacturing, with MSD as its anchor customer.
Its shares rose nearly 2% on June 4 after all this news.