1
QUESTIONS
TO THE COMMITTEE
1. Do data from
the pivotal study provide substantial evidence of safety and efficacy of daptomycin in the treatment of S.
aureus bacteremia?
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.
a. If your response is yes, are there specific comments that you have regarding the product label?
b. 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
NDA 21-572/S-008