Home » IVAX Receives Tentative Approval for Levofloxacin Tablets
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.
KEYWORDS Drug Pipeline Alert
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