 "Lupin Pharma")
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 $27 million in the US, Lupin said citing IQVIA MAT November 2023 data.
Last week, Lupin had launched a product, used as an aid to smoking cessation treatment, in the US market.
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The company has launched Varenicline tablets in strengths of 0.5 mg and 1 mg, after having received approval from USFDA, the Mumbai-based drug maker said in a regulatory filing.
The company's product is the generic equivalent of PF Prism CV's Chantix tablets, it added.
It is indicated for use as an aid to smoking cessation treatment.
As per the IQVIA data, Varenicline tablets had estimated annual sales of $412 million in the US.
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