Label Changes for:

Genotropin (somatropin [rDNA origin] for injection)

June 2008

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 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Clinical Trials in Children with Idiopathic Short Stature
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