Diflucan News |
NEW DELHI Dr. Reddy's Laboratories, India's second-biggest drug maker by sales, received tentative approval to sell its copy of the anti-fungal drug fluconazole in the United States, a statement on the Food and Drug Administration's Web site said Tuesday.
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Dr. Reddy's, based in Hyderabad, got approval from the regulator to sell tablets of fluconazole, the main ingredient in Pfizer's Diflucan, which had $662 million in U.S. sales last year.
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The approval is the first step toward sale of the drug in the United States. The company needs final approval from the regulator and Pfizer's patent has to expire before it can begin selling the drug there.
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Pfizer's patent on the drug expires July 29.
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