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Indoco gets USFDA nod for Febuxostat tablets

"Indoco Remedies received final approval of its ANDA (Abbreviated New Drug Application) 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 company said in a filing to the BSE.

December 31, 2019 / 02:09 PM IST
 
 
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Indoco Remedies on Tuesday said it has got final approval from the US health regulator for Febuxostat tablets used for the treatment of gout caused by excessive levels of uric acid in the blood.

The market size of Febuxostat tablets in the US is over USD 500 million (around Rs 3,565 crore).

"Indoco Remedies received final approval of its ANDA (Abbreviated New Drug Application) 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 company said in a filing to the BSE.

Febuxostat is used for the treatment of gout caused by excessive levels of uric acid in the blood (hyperuricemia). It 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.

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"Receipt of ANDA approval for Febuxostat Tablets for the US market is very encouraging and has added another feather to Indoco's cap," company's MD Aditi Kare Panandikar said.

Mumbai-based Indoco Remedies is a research-oriented pharma company with a presence in 55 countries.

Shares of Indoco Remedies were trading at Rs 193 apiece, up 0.31 per cent, on the BSE.



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PTI
first published: Dec 31, 2019 01:59 pm
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