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Tentative approval for Teva's Levofloxacin Injection
Jerusalem | Tuesday, February 15, 2005, 08:00 Hrs  [IST]

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.

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