QUESTIONS TO THE COMMITTEE
Do data from the pivotal study provide substantial
evidence of safety and efficacy of daptomycin in the
Please include in your deliberations a discussion of the
significance of patients with persistent or relapsing
bacteremias, and whose staphylococcal isolates had
increasing MICs to daptomycin.
If your response is yes, are there specific
comments that you have regarding the product
If your response is no what additional study or
studies would you recommend?
Center for Drug Evaluation and Research
Anti-Infective Drugs Advisory Committee
March 6, 2006