Ivax Corporation received final approval for its Abbreviated New Drug Application (ANDA) from the US FDA for fluconazole tablets in 50, 100, 150, and 200 mg dosage strengths.
Fluconazole is the generic equivalent of Diflucan, an antifungal agent marketed by Pfizer to treat yeast infections. US sales for fluconazole tablets were $475 million during 2003. The product will be sold through Ivax's wholly owned subsidiary, Ivax Pharmaceuticals, Inc.
Ivax continues its aggressive programme to increase the number of products in its generic portfolio, company said in a release.
Ivax Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the US and internationally.