Thalidomide (marketed as Thalomid) Information

Patient Information

• Patient Information Sheet [HTML] [PDF]
• Frequently Asked Questions and Answers about Thalidomide  [HTML]

Healthcare Professional Information

• Labeling and Regulatory History of Thalidomide from Drugs@FDA

Other Information

• FDA Talk Paper [HTML]
• Approval Letter [PDF]
• Thalidomide:   Potential Benefits and Risk.  An Open Public Scientific Workshop Sponsored by the National Institutes of Health and the Food and Drug Administration, September 9-10, 1997, Bethesda, MD.
• Executive Summary; Sep 9, 1997 Transcript; Sep 10, 1997 Transcript
• FDA's Medical Review of  Thalidomide Clinical Development
• Forty-Seventh Meeting of the Dermatologic and Opthalmic Drugs Advisory Committee, Center for Drug Evaluation and Research; Food and Drug Administration, September 4-5, 1997, Bethesda, MD.;
  Sep 4, 1997 Transcript.  271 pages.  Word or PDF
  Sep 5, 1997 Transcript.  211 pages.  Word or PDF

Supplementary Information Resources

These additional information resources available on the FDA and National Library of Medicine web sites provide some useful background information on this topic.

• Milestones in U.S. Food and Drug Law History.  FDA, 1995.

• FDA Issues Approvable Letter to Celegene for Thalidomide:  Talk Paper, FDA, Sep 19, 1997.

• Giving Thalidomide a Second Chance, by Herbert Burkholz.  FDA Consumer, Sep-Oct 97.

• Thalidomide:   Potential Benefits and Risks. Current Bibliographies in Medicine 97-4.   Bethesda, MD:  National Library of Medicine, 1997.  Contains 1495 citations to the medical literature on thalidomide from January 1963 through July 1997.

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