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GeneSoft Factive for mild to moderate CAP

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's Anti-Infective Drugs Advisory Committee recommends approval of GeneSoft's Factive (gemifloxacin) for community-acquired pneumonia (18-0, one abstention) and acute bacterial exacerbation of chronic bronchitis (15-3, one abstention) during March 4 review. Committee members suggested limiting the CAP indication for the quinolone antibiotic to mild to moderate pneumonia due to multi-drug resistant strains for a seven-day treatment period. FDA raised safety concerns about rash, QT prolongation and hepatotoxicity. Study data showed rash rates in women under 40 to be 31.7% for Factive versus 4.3% for ciprofloxacin. The committee said the incidence of rash should be included in labelin
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