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U.S. Department of Health and Human Services

Safety

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Omnitrope Pen 10 (somatropin [rDNA origin] injection), For Subcutaneous Use, For use with Omnitrope (somatropin [rDNA origin] injection) 10 mg/1.5 mL Cartridges August 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 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. Read about the new physician labeling format.


Summary View

Sections Modified

INSTRUCTIONS FOR USE (new)