Ranbaxy gets tentative U.S approval for fluconazole tablets
Wednesday, 07 May 2003, 19:30 IST
Printer Print Email Email
NEW DELHI: India's pharmaceutical major Ranbaxy Laboratories Ltd (RLL) has received tentative approval from the U.S. Food and Drug Administration to manufacture and market the generic version of Pfizer's Diflucan tablets used for treatment of vaginal infection. Pfizer Central Research holds the patent for the anti-fungal drug Diflucan till January next year, Ranbaxy said in a statement Tuesday. With this approval, Ranbaxy will be able to manufacture and market Fluconazole, the generic version of Diflucan, tablets in 50 mg, 100 mg, 150 mg, and 200 mg dosages. Pfizer's Diflucan is indicated for the treatment of vaginal candidiasis (vaginal yeast infections due to Candida), oropharyngeal and esophageal candidiasis, and cryptococcal meningitis. It is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy, according to Ranbaxy. Last year, sales for Fluconazole tablets in the U.S. totalled $422.2 million, representing 68 percent of the total $624.7 million global sales. "This further strengthens our expanding product portfolio and our commitment to bring generic alternatives into the U.S. healthcare system. The approval is yet another testimony to our strong intellectual and regulatory expertise," said Dipak Chattaraj, president of U.S. based subsidiary Ranbaxy Pharmaceuticals Inc. For 2002, Ranbaxy's U.S. operations achieved sales of $296 million, a growth of 162 percent over the previous year.
Source: IANS
siliconindia