Ivax Corporation has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for levofloxacin tablets in 250, 500 and 750 mg dosage strengths.
Levofloxacin tablets is the generic equivalent of Levaquin Tablets, a quinolone antibiotic used to treat lung, sinus, skin and urinary tract infections caused by bacteria, is marketed by Ortho-McNeil Pharmaceuticals, Inc.
According to IMS data, US sales for Levaquin Tablets in 250, 500 and 750 mg dosage strengths were $1.2 billion for the twelve months ended March 31, 2005.