Teva Pharmaceutical Industries Ltd. has announced here that the US FDA has granted tentative approval for the Company's ANDAs for Levofloxacin Injection, 5 mg/mL in 250 mg/bag and 500 mg/bag (5% dextrose bags) and Levofloxacin Injection, 25 mg/mL in 20 mL and 30 mL vials. Final approval is subjected to the resolution of ongoing patent litigation.
Teva's Levofloxacin Injection is the AP-rated generic equivalent of Ortho McNeil's broad-spectrum antibacterial agent Levaquin Injection.
Total annual sales of the brand product, in both configurations, are approximately $220 million.