Indoco gets US FDA nod for febuxostat tablets.
Indoco Remedies received final approval of its Abbreviated new drug application (ANDA) for febuxostat tablets 40 mg and 80 mg from US Food and Drug Administration (FDA).
This febuxostat tablets 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 over US$ 500 million.
Febuxostat is used for the treatment of gout caused by excessive levels of uric acid in the blood (hyperuricemia).
Febuxostat tablets 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.
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.”