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USFDA's nod for Ranbaxy tablets

Our Bureau

NEW DELHI: Ranbaxy Laboratories Ltd has received the approval from the US Food and Drug Administration (USFDA) to manufacture and market Fluconazole tablets and suspensions used for treatment of some infections caused by candida, a yeast-like fungus, usually affecting the skin and mucous membranes.

According to a company statement, "The Office of Generic Drugs, USFDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Diflucan of Pfizer Central Research." The total sale for Fluconazole is estimated to be $741 million - tablets accounting for $469 million and suspensions for the remaining $28 million.

Diflucan (Fluconazole) is indicated for the treatment of vaginal candidiasis (vaginal yeast infections due to candida), oropharyngeal and esophageal candidiasis (oral infections), and cryptococcal meningitis (a fungal brain infection). Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

Mr Jim Meehan, Vice-President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc said, "This (product) further expands our anti-infective product portfolio and supports Ranbaxy's role to provide affordable generic alternatives in the area of infectious diseases. Product will be made available to all customers immediately."

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