Ivax Corporation received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin Tablets USP, in 100 mg, 250 mg, 500 mg and 750 mg strengths.
Upon final approval, this product will be sold through the company's wholly owned subsidiary, Ivax Pharmaceuticals Inc.
Ciprofloxacin is the generic equivalent of Cipro, which is an antibiotic marketed by the Bayer Corporation for the treatment of a broad range of bacterial infections. U.S. sales of Cipro tablets in 100, 250, 500 and 750 mg dosage strengths were over $1.1 billion for the past twelve months ending in the second quarter of 2003.