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
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