Antibiotic Efficacy Rereview Would Be Triggered Only By Safety Issues – FDA
Absent safety concerns, FDA is not planning to seek superiority trials for currently-marketed antibiotics, despite advisory committee concerns about the approval standards used for Sanofi-Aventis' Ketek (telithromycin)
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Sanofi-Aventis' Ketek should not be the first-line treatment for community acquired pneumonia, members of an FDA advisory panel cautioned when they recommended continued marketing of the antibiotic for CAP
FDA's Anti-Infective Drug and Drug Safety and Risk Management Advisory Committees are recommending stripping Sanofi-Aventis' Ketek of its bronchitis and sinusitis indications
Pharma companies may need to place increased emphasis on discovery and development of novel anti-infective agents in order to address the proliferation of multidrug-resistant gram-negative infections