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Advisory committee to review two antibiotics

Executive Summary

The Anti-Infective Drugs Advisory Committee will review Johnson & Johnson's ceftobiprole medocaril Feb. 27, and Theravance/Astella's telavancin Feb. 28. Committee discussion may center on the use of non-inferiority studies to support the applications for the treatment of complicated skin and skin structure infections; such designs are discouraged by draft FDA guidance, and the agency may want reassurance on efficacy questions (1"The Pink Sheet" Oct. 22, 2007, p. 17)...

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