Label Changes for:
Lupron Depot (leuprolide acetate) suspension
June 2011
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) – June 2011
ADVERSE REACTIONS
Changes in Bone Density
- Table 4 is revised to add the 95% confidence intervals (CIs) for the mean percent change from baseline in bone mineral density of lumbar spine in women treated with Lupron alone or Lupron plus norethindrone acetate.
Postmarketing
- minor editorial/formatting changes
