Viagra Information

The Food and Drug Administration (FDA) and Pfizer Inc. are advising doctors about new warnings and information in the product labeling for Viagra (sildenafil) in response to postmarketing reports of serious adverse events. The new information augments the original drug labeling which warned against the concomitant use of Viagra and nitrates.

Revised in consultation with FDA, the new labeling is intended to help make sure that consumers and doctors are fully informed about the benefits and risks of using Viagra, know that consideration must be given to the cardiovascular status of patients prior to prescribing Viagra, and know how to safely use the drug.

The FDA approved Viagra on March 27, 1998.  Viagra is the first oral pill to treat impotence, a dysfunction that affects millions of men in the United States. Viagra is manufactured by Pfizer Pharmaceuticals, New York, NY. More information about Viagra can be found below, including updated labeling, new prescribing information, safety updates, consumer information, and the clinical review of the studies.

• FDA Talk Paper--Pfizer Updates Viagra Labeling (11/24/1998)

• New Viagra Prescribing Information (11/24/1998)

• FDA Labeling Supplement Approval Letter (11/24/1998)

• Revised Viagra Label (11/24/1998)

• Dear Health Professional Letter About Viagra (Safety Notice) (5/1998)

• FDA Talk Paper on Viagra Approval (3/27/1998)

• Viagra Approval Letter (3/27/1998)

• Viagra Information for Consumers (3/27/1998)

• Questions and Answers about Viagra (3/27/1998)

• Amendment to Clinical Review of 22 January 1998: Effects of Sildenafil on the Electroretinogram in Study 148-232 (5/13/1998)

• FDA's Clinical, Statistical and Biopharmacological Review of Viagra Clinical Development

  1. Cover Sheet (3/27/1998)

  2. Joint Clinical Reviews (3/27/1998)

     A. Table of Contents
     B. Sections 1-6
     C. Section 7
     D. Section 8
     E. Section 9-10
     F. Appendix A, Sections 1-4
     G. Appendix A, Sections  5-9
     H. Appendix A, Sections 10-13
     I. Appendix A, Sections 14-22
     J. Appendix A, Sections 23-33
     K. Appendix A, Sections 34-43
     L. Appendix A, Sections 44-51
     M. Appendix A, Sections 52-56

  3. Chemistry Review (3/27/1998)

  4. Pharmacology Reviews (3/27/1998)

     A. Review and Evaluation of Pharmacology and Toxicology Data, Pages 1-25
     B. Review and Evaluation of Pharmacology and Toxicology Data, Pages 26-48
     C. Review and Evaluation of Pharmacology and Toxicology Data, Pages 49-65
     D. Review and Evaluation of Pharmacology and Toxicology Data, Pages 66-90
     E. Review and Evaluation of Pharmacology and Toxicology Data, Pages 91-116
     F. Review and Evaluation of Pharmacology and Toxicology Data, Pages 117-142

  5. Statistical Carcinogenicity Reviews (3/27/1998)

     A. Carcinogenicity Review of Sildenafil in Rats and Mice
     B. Appendix A, Male Rats
     C. Appendix B, Female Rats
     D. Appendix C, Male Mice
     E. Appendix D, Female Mice

  6. Carcinogenicity Assessment Committee and FDA/CDER Rodent Carcinogenicity Database Factsheet (3/27/1998)

  7. Administrative Documents (3/27/1998)

  8. Correspondence (3/27/1998)

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