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Business Update
Generics producer granted rights for fluconazole, intends to file antiretroviral
September 5th, 2004
Ranbaxy Laboratories Limited (RLL) announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Fluconazole Tablets and Oral Suspension. The tablets will be available in 50 mg, 100 mg, 150 mg, and 200 mg strengths and the oral suspension will be offered in 10 mg/mL (50 mg/5mL) and 40 mg/mL (200 mg/5mL). The Office of Generic Drugs, FDA, 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...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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