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U.S. Department of Health and Human Services

Safety

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Lupron Depot (leuprolide acetate) for depot suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011

Summary View

 

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