Label Changes for:

Lupron Depot (leuprolide acetate for depot suspension), 11.25 mg

January 2012

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) – January 2012

 

ADVERSE REACTIONS

Postmarketing

Hepato-biliary disorder

  • rarely reported serious liver injury
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