Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the company's abbreviated new drug applications (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.
Teva's Levofloxacin injection is the generic equivalent of Ortho McNeil's broad-spectrum antibacterial agent Levaquin injection.
Teva noted that the total annual sales of the brand product, in both configurations, are approximately $220 million.
Final approval is subject to the resolution of ongoing patent litigation in the U.S. District Court for the District of New Jersey.
On January 27, Teva announced it had received final approval from the FDA of its ANDA for Levofloxacin tablets 750 mg., the generic equivalent of Ortho McNeil Pharmaceutical Levaquin tablets. Teva was awarded 180 days of generic drug exclusivity for the product but shipment will not commence until a decision in the patent litigation.
Published by Globes [online], Israel business news - www.globes.co.il - on Sunday, February 13, 2005