Ivax Corporation has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ciprofloxacin tablets in 250 mg, 500 mg and 750 mg strengths and tentative approval for the 100 mg strength, according to company release.
This product will be sold through the company's wholly-owned subsidiary Ivax Pharmaceuticals Inc. Ivax Corporation, headquartered in Miami, Florida, develops generic pharmaceuticals and veterinary products in the US and internationally.
Ciprofloxacin is the generic equivalent of Cipro, which is an antibiotic marketed by Bayer Pharmaceuticals Corporation. US sales of Cipro in the 250 mg, 500 mg and 750 mg dosage strengths were over $1.0 billion in 2003.