Indoco Remedies receives approval for Febuxostat Tablets

31 Dec 2019 Evaluate

Indoco Remedies has received final approval of its Abbreviated New Drug Application (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 USA is over $500 million. Febuxostat is used for the treatment of gout caused by excessive levels of uric acid in the blood (Hyperuricemia).

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.

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