Indoco Remedies has received final USFDA approval for febuxostat tablets 40 mg and 80 mg from US Food and Drug Administration (FDA), which is therapeutically equivalent to the reference listed drug (RLD), viz., Uloric tablets 40 mg and 80 mg of Takeda Pharmaceuticals U.S.A., Inc.
The market size of febuxostat tablets in USA is estimated at US$ 450 million.
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.