In separate announcements, Miami drug maker Ivax Corp. (Amex: IVX) said it has received tentative U.S. approval to sell generic antifungal tablets and its Ivax Pharmaceuticals subsidiary has begun distributing generic amoxicillin.
The antifungal news relates to Ivax's request to sell a generic version of Diflucan, a Pfizer drug marketed to treat yeast infections. Ivax put U.S. sales for fluconazole tablets at $475 million during 2003. The company indicated it intends to sell the fluconazole tablets in 50 mg, 100 mg, 150 mg and 200 mg dosage strengths. The type of approval the U.S. Food and Drug Administration gave Ivax for the antifungal - tentative - means the FDA deemed the drug ready for approval, but has delayed final approval until all patent or exclusivity issues are resolved. A company many not market a drug until final approval. For generic amoxicillin, Ivax said its tablets, capsules, chewable tablets and oral suspension are supplied and licensed by GlaxoSmithKline. The amoxicillin, Ivax added, is the equivalent of Amoxil, a penicillin antibiotic GlaxoSmithKline markets to treat bacterial infections affecting the ear, nose, throat, lower respiratory tract, urinary tract and skin. U.S. sales for amoxicillin were $201 million for 2003, Ivax said.
Ivax shares closed up a penny to $23.38. The 52-week high was $26.85 on Jan. 27. The 52-week low was $10.85 on March 24.
© 2004 American City Business Journals Inc.
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