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Medical Letter on the CDC & FDA

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Generic Drugs



Pharmaceutical company receives U.S. FDA approval for generic antifungal agent



February 20th, 2005

Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the company's ANDA for fluconazole injection, 2 mg/mL in 200 mg and 400 mg bags. A launch date has not yet been finalized.

Fluconazole is the generic equivalent of Pfizer's antifungal agent Diflucan.

Total annual sales of this configuration of fluconazole injection, including brand and generic sales, are approximately $167 million.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is a generic pharmaceutical company that develops, manufactures and markets generic and innovative human...


Source: Medical Letter on the CDC & FDA (2005-02-20)

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