U.S. FDA tentatively approves Ranbaxy's drug
NEW DELHI: The approval is for manufacturing and marketing oral Fluconazole suspension, a generic version of Pfizer's Diflucan suspension in dosages of 10mg/ml and 40mg/ml, a Ranbaxy statement said Monday.
Pfizer Central Research holds the patent for Diflucan till January 2004.
Ranbaxy had received tentative approval in May for manufacturing and marketing Fluconazole tablets in 50 mg, 100 mg, 150 mg, and 200 mg dosages.
Diflucan is recommended for treating vaginal yeast infections caused by candida, oropharyngeal and esophageal candidiasis and cryptococcal meningitis.
Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplants who receive cytotoxic chemotherapy and/or radiation therapy.
Sales and marketing for Fluconazole will be supported by New Jersey based Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL).
Said RPI president Dipak Chattaraj: "Adding an anti-fungal molecule as a liquid formulation to our expanding product portfolio reflects our breadth of expertise and demonstrates our commitment to bring generic alternatives to the U.S. healthcare system that have clinical utility and value to prescribers and patients."
RPI was ranked as the ninth largest in the U.S. generics market in 2002.
Source: IANS