Historical Information on Viagra (sildenafil citrate)

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.

• Information for Healthcare Professionals Sheet (7/8/2005)
• 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)
• Dear Health Professional Letter About Viagra (Safety Notice) (5/1998)
• FDA Talk Paper on Viagra Approval (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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Date created: October 18, 2007

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