FDA to Review New Generation Topical Quinolone for Impetigo
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.
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.