Teva Announces Final Approval of Levofloxacin Tablets, 750 mg

The FDA has granted final approval for Teva Pharmaceutical's abbreviated new drug application (ANDA) for levofloxacin tablets, 750 mg.

Teva's levofloxacin tablets are the AB-rated generic equivalent of Ortho-McNeil Pharmaceutical's broad spectrum antibiotic Levaquin tablets.

As the first applicant to file an ANDA with a Paragraph IV patent certification, Teva has been awarded 180 days of generic drug exclusivity for levofloxacin tablets, 750 mg. Shipment of this product will not begin at least until a decision in the pending patent litigation in the U.S. District Court for the District of New Jersey.

In addition, Teva expects to receive final approval for its levofloxacin tablets in the 250- and 500-mg strengths upon the earlier of the expiration of another ANDA filer's 180-day marketing exclusivity, which has not started, or the expiration of the patent.