Cubist Pharmaceuticals announced that the FDA has granted Fast Track status to its late-stage antibiotic candidate, ceftolozane/tazobactam (CXA-201) for the treatment of hospital-acquired bacterial pneumonia (HABP)/ acquired bacterial pneumonia (VABP) and complicated urinary tract infections (cUTI). Ceftolozane/tazobactam was previously designated Qualified Infection Disease Product (QDIP) for these indications.
Ceftolozane/tazobactam is being studied in Phase 3 trials as a potential intravenous therapy for the treatment of cIAI and cUTI caused by gram-negative pathogens and multi-resistant Pseudomonas aeruginosa. A Phase 3 VABP program for ceftolozane/tazobactam is expected to be initiated by mid-year.
In February 2013, Cubist was granted Fast Track status for ceftolozane/tazobactam in complicated intra-abdominal infections (cIAI).
For more information call (866) 793-2786 or visit www.cubist.com.