This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryJune 1 "approvable" letter for the once-daily, oral ketolide antibiotic covers indications for treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis. Ketek was designated "not approvable" for tonsillitis/pharyngitis. FDA's Anti-Infective Drugs Advisory Committee recommended approval April 26 for the CAP indication, but recommended against clearance for acute sinusitis and ABECB. Tonsillitis/pharyngitis treatment was not discussed
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