Aventis Ketek
Executive Summary
FDA requests additional data from Aventis on Ketek (telithromycin) in "approvable" letter for treatment of community acquired pneumonia, bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis. Tonsillitis/pharyngitis indication is "not approvable," letter adds
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Aventis' 24,000-patient "usual care" study for Ketek should be the benchmark for investigational antibiotic safety trials, FDA Anti-Infective Drugs Advisory Committee voting consultant William Lee, MD, University of Texas Southwestern Medical School, said Jan. 8
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Aventis' 24,000-patient "usual care" study for Ketek should be the benchmark for investigational antibiotic safety trials, FDA Anti-Infective Drugs Advisory Committee voting consultant William Lee, MD, University of Texas Southwestern Medical School, said Jan. 8
Aventis Ketek Will Return To FDA Advisory Committee Jan. 8
FDA's Anti-Infective Drugs Advisory Committee will review the safety profile of Aventis' Ketek (telithromycin) on Jan. 8, Exec VP-Commercial Operations Thierry Soursac told an investor conference call Oct. 29