Lupin receives USFDA approval to market generic Febuxostat tablets for the treatment of hyperuricemia in adults with gout. The drug, a generic equivalent of Uloric, will be manufactured in India.
Photograph: Kind courtesy Gerd Altmann/Pixabay
New Delhi, Jan 18 (PTI) Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing.
The product will be manufactured at the company's Pithampur facility in India, it added.
The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) 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.
Febuxostat tablets had estimated annual sales of USD 27 million in the US, Lupin said citing IQVIA MAT November 2023 data.
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