US FDA approves Dr. Reddy's ANDA for fluconazole.

The United States Food and Drug Administration has approved Dr. Reddy’s Abbreviated New Drug Application (ANDA) for fluconazole tablets 50 mg, 100 mg, 150 mg and 200 mg on July 29, 2004.

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.