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U.S. Department of Health and Human Services


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Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets

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 from Clinical Trials Experience
    • Study 934
      • Table 2
    • Laboratory Abnormalities
      • Table 3

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