Halcion: An Independent Assessment of Safety and Efficacy Data (1997)
Chapter: Appendix E: Resources Reviewed by the Committee
E
Resources Reviewed by the Committee
Title | Contents | Source |
General background | ||
FDA Task Force Report |
| FDA |
Public Citizen Petition | The Public Citizen Petition to Remove Halcion from the Market | Public Citizen |
Upjohn Response to Petition | Upjohn's Response to the Public Citizen Petition | FDA |
IOM Study on Sleep | Basic Sleep Research, 1990 | IOM |
IOM Study on Sleeping Pills | Sleeping Pills, Insomnia, and Medical Practice, 1979 | IOM |
Miscellaneous information provided by Upjohn | Sales data, patent data, and information on generic compounds | Upjohn |
Miscellaneous information provided by FDA | Summary basis of approval, labeling information, information on generic compounds, and guidelines for the clinical evaluation of hypnotic drugs | FDA |
Published literature | ||
IOM search | Articles concerning Halcion | IOM |
Literature on Halcion |
| FDA |
Title | Contents | Source |
Upjohn literature search | Literature search identifying later studies | Upjohn |
Literature provided by Public Citizen | All cited references, including Kales (1996), A Reassessment of Triazolam and Conflicting Scientific Expertise in British and American Medicines Control | Public Citizen |
International data | ||
Canadian product monograph for Halcion |
| Canada |
Evaluations of Medications for Insomnia in Canada (EMIC) |
| Upjohn |
Medicines Control Agency letter | Letter from the Licensing Authority to Upjohn, 1992 | Public Citizen |
Report of the Committee on Proprietary Medicinal Products |
| Upjohn |
Report of the Committee on the Safety of Medicines |
| Public Citizen |
UK Panel Report | Report of the Panel of Persons Appointed | United Kingdom |
VAMP Information | Information on the General Practice Research Database (previously known as the Value Added Medical Practice [VAMP] Database) | Upjohn |
Premarketing clinical trial data (from the New Drug Application) | ||
Preapproval reviews |
| FDA |
Premarketing clinical trials |
| FDA |
Report of the database remake |
| FDA |
Title | Contents | Source |
Upjohn summaries of non-pivotal clinical trials |
| FDA |
Efficacy protocols | Protocols for 20 studies with lower dosages reviewed for efficacy | Upjohn |
Information from FDA Psychopharmacologic Drugs Advisory Committee meetings | ||
Transcript of the PDAC meetings: 1977, 1989, 1992 |
| FDA |
FDA mailing to 1989 and 1992 PDACS | FDA mailing to 1989 PDAC | Upjohn |
Brochures with summary information prepared by Upjohn for the PDAC meetings, 1989 and 1992 | Upjohn brochure prepared for the PDAC 1989 | Upjohn |
Integrated Summaries of Safety and Efficacy | ||
Integrated safety study | Integrated studies' of safety | Upjohn |
Integrated efficacy study | Integrated studies of effectiveness | Upjohn |
Integrated dropout listings | Integrated summary of safety dropout listings | Upjohn |
Statistical reviews |
| FDA |
Epidemiological reviews |
| FDA |
Pharmocokinetic and pharmacodynamic data |
| Upjohn |
Postmarketing surveillance data | ||
Annual Adverse Event Reports |
| FDA |
Postmarketing protocols: 1994-1996 | Protocols, M/2100/0235, M/2100/0366, and M/2100/0373 | FDA |
Upjohn Annual Reports to FDA, 1990-1997 |
| FDA |
Title | Contents | Source |
Spontaneous report data | ||
FDA memoranda | FDA memoranda provided by Diane Wysowski | FDA |
SRS data | Data on the FDA Spontaneous Reporting System | FDA |
Use, sales, and prescription data | ||
IMS statistics | IMS statistics regarding reasons for prescriptions, high dose usage, and chronic usage | Upjohn |
Use statistics | Use statistics from IMS and health maintenance organization data regarding reasons for prescriptions, high dose usage, and chronic usage | FDA |
Sales information | Number of packages sold in the United States, 1982-1997 | Upjohn |
