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Halcion An Independent Assessment of Safety and Efficacy Data (1997) / Chapter Skim
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Appendix E: Resources Reviewed by the Committee
Pages 146-149

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From page 146...
... EResources Reviewed by the Committee Title Contents Source General background FDA Task Force Report FDA Public Citizen Petition The Public Citizen Petition to Public Citizen Remove Halcion from the Market Upjohn Response to Petition Upjohn's Response to the Public FDA Citizen Petition lOM Study on Sleep Basic Sleep Research, 1990 lOM IOM Study on Sleeping Pills Sleeping Pills, Insomnia, and lOM Medical Practice, 1979 Miscellaneous Sales data, Upjohn information provided by patent data, and Upjohn information on generic compounds Miscellaneous Summary basis of approval, FDA information provided by labeling information, FDA information on generic compounds, and guidelines for the clinical evaluation of hypnotic drugs Published literature lOM search Articles concerning Halcion TOM Literature on Halcion FDA 146
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From page 147...
... Medicines Control Letter from the Licensing Authority Public Citizen Agency letter to Upjohn, 1992 Report of the Committee Upjohn on Proprietary Medicinal Products Report of the Committee Public Citizen on the Safety of Medicines UK Pane} Report Report of the Pane! of Persons United Appointed Kingdom VAMP Information Information on the General Practice Upjohn Research Database (previously known as the Value Added Medical Practice tVAMP]
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From page 148...
... 148 HALCION: AN INDEPENDENT ASSESSMENT Title Contents Source Upjohn summaries of non-pivotal clinical trials Efficacy protocols FDA Protocols for 20 studies with lower Upjohn dosages reviewed for efficacy Information from FDA Psychopharmacologic Drugs Advisory Committee meetings Transcript of the PDAC meetings: 1977, 1989, 1992 FDA mailing to 1989 and 1992 PDACs Brochures with summary information prepared by Upjohn for the PDAC meetings, 1989 and 1992 FDA FDA mailing to 1989 PDAC Upjohn Upjohn brochure prepared for the Upjohn PDAC 1989 Integrated Summaries of Safety and Efficacy Integrated safety study Integrated efficacy study integrated dropout listings Statistical reviews Epidemiological reviews Pharmocokinetic and pharmacodynamic data Postmarketing surveillance data Annual Adverse Event Reports Postmarketing protocols: 1994-1996 Upjohn Annual Reports to FDA, 1990- 1997 Integrated studies of safety Integrated studies of effectiveness Integrated summary of safety dropout listings Protocols, M/2100/0235, M/2100/0366, and M/2100/0373 Upjohn Upjohn Upjohn FDA FDA Upjohn FDA FDA FDA
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From page 149...
... APPENDIX E 149 Title Contents Source Spontaneous report data FDA memoranda FDA memoranda provided by Diane FDA Wysowski SRS data Data on the FDA Spontaneous FDA Reporting System Use, sales, and prescription data IMS statistics IMS statistics regarding reasons for Upjohn prescriptions, high dose usage, and chronic usage Use statistics Use statistics from IMS and health FDA maintenance organization data regarding reasons for prescriptions, high dose usage, and chronic usage Sales information Number of packages sold in the Upjohn United States, 1982-1997
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Key Terms

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  • clinical trials
  • medicines control
  • value added
  • drug application

  • agency letter
  • added medical
  • research database
  • clinical trial
  • preapproval reviews

  • vamp information
  • database remake
  • remake fda
  • proprietary medicinal
  • licensing authority

  • fda fda


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