Alembic Pharmaceuticals shares rallied nearly 6 percent intraday on July 2 as the US health regulator approved Febuxostat tablets that lower uric acid levels.
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.
"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," Alembic said in its filing.
The approved ANDA is therapeutically equivalent to reference listed drug (RLD), Uloric tablets of Takeda Pharmaceuticals USA, Inc.
Febuxostat tablets have an estimated market size of $578 million for twelve months ending December 2018 according to IQVIA, the company said.
Alembic further said it now has a total of 98 ANDA approvals (87 final approvals and 11 tentative approvals) from USFDA.
The stock was quoting at Rs 525.25, up Rs 21.70, or 4.31 percent on the BSE at 1002 hours IST.
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