The US FDA has approved Dr Reddy's Abbreviated New Drug Application (ANDA) for fluconazole tablets 50 mg, 100 mg, 150 mg and 200 mg, company informed in a release.
Fluconazole is the generic equivalent of Pfizer's Diflucan and is indicated for the treatment of vaginal yeast infections.
As per IMS (MAT) March 2004, the product had annual US brand sales of approximately US $ 712 million of which the tablets (oral solids) had a total sales of US $ 476 million.