This article is more than 5 years old. Information may no longer be current.

Generic levofloxacin granted FDA approval

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

AMITYVILLE, N.Y. — Hi-Tech Pharmacal’s abbreviated new drug application for levofloxacin ophthalmic solution 0.5% has been approved by the Food and Drug Administration, according to a press release. Hi-Tech’s drug is the generic equivalent of Santen’s Quixin, the company said. The generic drug has been approved for the treatment of bacterial infections.

In 2003 Daiichi, which has licensed its patent on the drug to Santen, filed a complaint against Hi-Tech for patent infringement. Hi-Tech filed a counterclaim in early 2004. Currently no trial date has been set. Hi-Tech expects to start marketing its product pending the outcome of the patent litigation with Daiichi.