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U.S. Department of Health and Human Services

Safety

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Emtriva (emtricitabine) Capsules and Oral Solution May 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 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

  • Adverse Reactions from Clinical Trials Experience
    • Adult Patients
    • Study 934 - Treatment Emergent Adverse Reactions
      • Table 4
    • Laboratory Abnormalities
      • Table 5

Label approved 05/16/2008 is not available on Drugs@FDA