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Label Changes for:

Orencia (abatacept) powder for injection

August 2009

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) -- August 2009


Clinical Experience in MTX-Naive Patients
  • Study VI was an active-controlled clinical trial in MTX-naive patients [see Clinical Studies (14.1)]. The safety experience in these patients was consistent with Studies I-V