FDA to Review New Generation Topical Quinolone for Impetigo

Two trials showed that ozenoxacin demonstrated superior bacteriological cure vs. placebo
Two trials showed that ozenoxacin demonstrated superior bacteriological cure vs. placebo

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ozenoxacin 1% cream (Medimetriks) for the treatment of impetigo.

Medimetriks submitted the application to the FDA in June 2016 which was supported by clinical data from two successful Phase 3 studies. Both trials showed that ozenoxacin demonstrated superior bacteriological cure vs. placebo, with an excellent antibacterial activity against a broad range of bacteria. The studies found that ozenoxacin has a tolerable safety profile in both adult and pediatric populations.  

Related Articles

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of June 22, 2017 for the completion of the NDA review.

Ozenoxacin is a novel generation of non-fluorinated quinolones under development for the potential treatment of a broad range of infectious dermatological conditions.

For more information visit Medimetriks.com.

Loading links....