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Dr Reddy's gets USFDA nod for Fluconazole

C.R. Sukumar

Hyderabad , May 25

IN a major boost to its patent challenging strategy, Dr Reddy's Laboratories Ltd, the Hyderabad-based global pharmaceutical major, has obtained the tentative approval of the United States Food and Drugs Administration (USFDA) for the abbreviated new drug application filed on Fluconazole, indicated for the treatment of fungal infection.

Currently, Pfizer holds patent on the product under the brand `Diflucan', which had a market of $447 million during the last year. The drug is scheduled to go off patent on July 29 this year.

Confirming the receipt of the tentative approval for Fluconazole, Dr Reddy's sources told Business Line that the company would initiate steps to launch the product in the US market after the expiry of patents once it receives the final approval from the USFDA.

"The USFDA's tentative approval is the first step toward sale of the drug in the US market. We need to get final approval from the regulator to launch the drug once the patent expires," sources said.

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