IVAX Receives Tentative Approval for Levofloxacin Tablets

The FDA has granted Ivax tentative approval for its abbreviated new drug application for levofloxacin tablets in 250-, 500- and 750-mg dosage strengths.

Levofloxacin is the generic equivalent of Ortho-McNeil Pharmaceuticals' Levaquin, a quinolone antibiotic used to treat lung, sinus, skin and urinary tract infections caused by bacteria. U.S. sales for Levaquin tablets in 250-, 500- and 750-mg dosage strengths totaled $1.2 billion for the 12 months ended March 31, Ivax said.