Ranbaxy Laboratories Limited (RLL) has received approval from the US Food and Drug Administration to manufacture and market Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg strengths and Fluconazole for Oral Suspension, 10 mg/mL (50 mg/5mL) and 40 mg/mL (200 mg/5mL).
The Office of Generic Drugs, US Food and Drug Administration, 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. Total market sales for Fluconazole were $741 million (IMS - MAT: March 2004). Tablet sales represented a total of $469 million and the suspension $28 million, the release from Ranbaxy said.
Diflucan (Fluconazole) is indicated for the treatment of vaginal candidiasis (vaginal yeast infections due to Candida), oropharyngeal and esophageal candidiasis, and cryptococcal meningitis. Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.