Indoco Remedies gets USFDA approval for Febuxostat Tab

Indoco Remedies has received the final USFDA 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 U.S.A., Inc.

The market size of Febuxostat tablets in the 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 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.

Earlier this month, its sterile manufacturing facility (Plant II) at Verna, Goa, received EU GMP certification from the UK Health Regulator, whose inspection was conducted by the UK MHRA from September 16 to 20, 2019.

On Tuesday, the stock of Indoco Remedies surged 2.5 per cent to Rs 197.15 from its previous close of Rs 192.40. Later it got closed at Rs 193.20.