Lupin Receives FDA Approval For Generic Fluconazole Tablets

Lupin, a pharma company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Fluconazole Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg, to market a generic equivalent of Diflucan Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of Pfizer, Inc, the company informed in a press statement on Monday.

The tablet is used to treat vaginal yeast infections by stopping the growth of common types of vaginal yeast. Fluconazole belongs to a class of drugs called azole antifungals.  

This product will be manufactured at Lupin’s Pithampur facility in India, the company's statement informed.

Fluconazole Tablets USP had estimated annual sales of USD 43 million in the US (IQVIA MAT July 2023), the statement stated.