Label Changes for:
Emend (aprepitant) capsules
March 2010
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010
ADVERSE REACTIONS
Clinical Trials Experience
- section (including Table 2) was updated to include the adverse experience data from the sponsor's completed postmarketing study.
CLINICAL STUDIES
Post-Marketing Trial
- Entire Section Updated
- In a postmarketing, multicenter, randomized, double-blind, parallel-group, clinical study in 848 cancer patients, the aprepitant regimen (N=430) was compared with a standard of care therapy (N=418) in patients receiving a moderately emetogenic chemotherapy regimen that included...
