FDA Grants Cerexa Fast Track Designation for PPI-0903

News | 03. 14. 2006


Cerexa, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PPI-0903, a next-generation, broad-spectrum, cephalosporin antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA). Cerexa initiated a Phase 2 trial of PPI-0903 for the treatment of cSSSI in October 2005. Under the FDA Modernization Act of 1997, the Fast Track program of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential to address unmet medical needs for such a condition.