The Troglitazone story
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US Food and Drug Administration
Approval
package APPLICATION NUMBER: 020720/S002,S003,S005. TRADE
NAME: Rezulin 200 mg and 400 mg Tablets. GENERIC NAME: Troglitazone.
SPONSOR: Parke Davis Pharmaceutical Research. Rezulin
(Troglitazone tablets). Company: Parke-Davis Pharmaceutical
Research. Application No: 020720/ S12, S14. Indications: Use of
Rezulin in combination with metformin and sulfonylurea in patients
with type 2 diabetes. Endocrinologic and Metabolic Drugs Advisory Committee. (1996) Endocrinologic and Metabolic Drugs Advisory Committee. (1999) Endocrinologic and Metabolic Drugs Advisory Committee. (2000) Lumpkin, Murray. (2000) Storey, Donna (2002) Talk papers and press releases FDA approves Rezulin for diabetes patients poorly controlled on insulin therapy. 30 January 1997. New type II diabetes drug may reduce insulin needs. FDA Consumer Magazine April 1997. Rezulin labeling changes. 3 November 1997. Patient testing and labeling strengthened for Rezulin. 1 December 1997. Patient testing, labelling strengthened for diabetes drug. News along the pike December 1997; 3(12):6. FDA approves rosiglitazone to treat type II diabetes. 26 May 1999. New labelling and use changes for Rezulin. 16 June 1999. FDA Approves pioglitazone to treat Type 2 diabetes. 16 July 1999. Rezulin to be withdrawn from the market. HHS News 2000. FDA to schedule public discussion of Rezulin. 24 March 2000. Summary of safety-related drug labelling changes approved by FDA, April 1997. Summary of safety-related drug labelling changes approved by FDA, August 1997. Summary of safety-related drug labelling changes approved by FDA, November 1997. Summary of safety-related drug labelling changes approved by the FDA, December 1997. Summary of safety-related drug labelling changes approved by the FDA, July 1998. Summary of safety-related drug labelling changes approved by the FDA, June 1999. Back to US Food and Drug Administration Askine, Mark W. (Regulatory Review Officer, Division of Drug
Marketing, Advertising and Communications) (1997). Thomson, Diane E. (Associate Commissioner for Legislative Affairs).
(1999) Jenkins, John K. (Director, Office of Drug Evaluation II, Centre
for Drug Evaluation and Research, FDA). (1999) Buse, John B. (Associate Professor of Medicine, University of
North Carolina and Director of the Diabetes Care Center). (2000) Back to US Food and Drug Administration Graham D, Green L. (2000) U.S. National Institutes of HealthVarmus, Henry (Director NIH). (1998) Varmus, Henry (Director NIH). (1999) U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD)USNIDDKD (1996) USNIDDK (1998)
U.S. NIH. National Diabetes Education ProgramUS. NIH. National Diabetes Education Program. (2004)Diabetes Prevention Program Fact Sheet. Bethesda, Md: NDEP. U.S. Patent OfficeU.S.
Patent 4,572,912 U.S.
Patent 5,478,852
U.S.
Patent 5,708,012 UK Committee on Safety of Medicines Troglitazone
(Romozin) withdrawn Sub-Committee on Pharmacovigilance, 29 September 1998. Summary of the meeting of the Sub-Committee on Pharmacovigilance held on 23 February 1999. Summary of the meeting of the Sub-Committee on Pharmacovigilance held on 27 April 1999 |