Teva Claims US FDA Tentative Approval for Levofloxacin Generic

Iraeli generics major Teva has reported that the US FDA has approved its ANDA for 750mg Levofloxacin broad spectrum antibiotic tablets. The approval awards Teva 180 days' exclusivity on the drug at the specified dose, as the company is reported to be the first to file an appropriate ANDA with a paragraph IV patent certification.

Nevertheless, there remain a number of potential obstacles to be overcome before the drug is likely to be launched. An earlier applicant is understood to have filed for the drug in the 250 mg and 500 mg formats, and Teva says it will await either the expiry of this ANDA or the patent itself, which was originally granted to US drug producer Ortho-McNeil Pharmaceutical. The company is also awaiting the outcome of a lawsuit in New Jersey, US.