Indoco receives approval for Febuxostat Tablets from US FDA

Indoco Remedies received final approval of its ANDA for Febuxostat Tablets 40 mg and 80 mg, which is therapeutically equivalent to the Reference Listed Drug (RLD), viz., Uloric Tablets 40 mg and 80 mg of Takeda Pharmaceuticals USA, Inc.

The market size of Febuxostat Tablets in USA is over USD 500 million.

Indoco Remedies, Febuxostat Tablets, US FDA

Febuxostat is used for the treatment of gout caused by excessive levels of uric acid in the blood (Hyperuricemia). Febuxostat prevents the production of uric acid by blocking the activity of the enzyme (xanthine oxidase) that converts purines to uric acid. Uric acid forms crystals in joints and tissues, causing inflammation and pain. Hyperuricemia can cause kidney disease and kidney stones as well.

Commenting on this achievement, Ms. Aditi Kare Panandikar, Managing Director – Indoco Remedies Ltd. said, “Receipt of ANDA approval for Febuxostat Tablets for the US market is very encouraging and has added another feather to Indoco’s cap.”