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FDA Grants QIDP and Fast Track Designations for Cubist Pharmaceuticals, Inc. (CBST)'s Late-Stage Antibiotic Candidates



3/1/2013 9:54:21 AM

LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the U.S. Food and Drug Administration (FDA) has designated the company’s late-stage antibiotic candidate, ceftolozane/tazobactam, as a Qualified Infectious Disease Product (QIDP) for the indications of Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI). Additionally, the company received from the FDA notification that Cubist’s antibiotic candidates, ceftolozane/tazobactam and surotomycin, have been granted Fast Track status in their previously granted QIDP indications, Complicated Intra-Abdominal Infections (cIAI) and Clostridium difficile-Associated Diarrhea (CDAD) respectively.

Read at BioSpace.com


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