Shares of Alembic Pharmaceuticals surged nearly 6 percent on Tuesday after the US health regulator approved Febuxostat tablets.

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The stock gained as much as 5.8 percent to Rs 533 per share on the BSE. At 11:30 AM, the stock was trading 4.75 percent higher at Rs 527.45 per share as compared to 0.32 percent (125 points) fall in the BSE Sensex at 39,561.

"Company has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Febuxostat tablets, which are available in 40 mg and 80 mg strengths," the company said in its filing.

Alembic added that it now has a total of 98 ANDA approvals (87 final approvals and 11 tentative approvals) from USFDA.

"The approved ANDA is therapeutically equivalent to reference listed drug (RLD), Uloric tablets of Takeda Pharmaceuticals USA, Inc. Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable," it further added.

Febuxostat tablets have an estimated market size of $578 million for twelve months ending December 2018 according to IQVIA, the company said.

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