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New Delhi: Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic Fluconazole tablets used in the treatment of fungal infections. The approval granted by the US Food and Drug Administration (USFDA) for the abbreviated new drug application of Fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg, Lupin said in a regulatory filing.
These are the generic equivalents of Diflucan tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of Pfizer Inc, it added.
This product will be manufactured at Lupin’s Pithampur facility in India, the company said.
Fluconazole Tablets had estimated annual sales of USD 43 million in the US, Lupin said citing IQVIA MAT July 2023 data.
