Science Fair Project Encyclopedia
Rosuvastatin is available as Crestor in tablet form (10, 20, or 40 mg) for oral administration. Tablets are pink, round or oval (40 mg), biconvex, film-coated, and imprinted with "ZD4522" and tablet strength. Japanese approval is in the dose range of 2.5 mg to 20 mg; therefore, smaller dose tablet forms might also be available outside the United States. Note that 97% of worldwide sales have been at or below the 20 mg dose.
Mechanism of action
See the article on statins for more details.
Indications and regulation
Rosuvastatin is indicated for the treatment of elevated LDL cholesterol (dyslipidemia), total cholesterol (hypercholesterolemia) and/or triglycerides (hypertriglyceridemia).Annual Report and Form 20-F, Information 2004. Information from print version.
- AstraZeneca PLC (2004). Annual Report and Form 20-F, 2003. Retrieved 2005-03-20.
- McTaggart, F.; Buckett, L.; Davidson, R.; Holdgate, G.; McCormick, A.; Schneck, D.; Smith, G.; and Warwick, M. Preclinical and clinical pharmacology of rosuvastatin, a new 3-hydroxy- 3-methylglutaryl coenzyme A reductase inhibitor. Am J Cardiol 2001;87(5supp1);28-32. PMID 11256847.
- AstraZeneca PLC (June 17, 2003). Core Data Sheet, Crestor Tablets. Retrieved 2005-03-20. NOTE: this is provider-oriented information and should not be used without the supervision of a physician.
- ⇧ ibid.
- ⇧ The Food and Drug Administration (August 12, 2003). FDA Approves New Drug for Lowering Cholesterol. Press Release. Retrieved 2005-03-20.
- ⇧ Horton, Richard (October 25, 2003). The statin wars: why AstraZeneca must retreat. The Lancet 362(9393), 1341. PMID 14585629. Retrieved 2005-03-20. No author is listed with the online abstract; full-text is not available free online.
McKillop, Tom (November 1, 2003). The statin wars. The Lancet 362 (9394), 1498. PMID 14602449. Full-text is not available free online.
- ⇧ Rosuvastatin Calcium (marketed as Crestor) Information (March 14, 2005). FDA Alert (03/2005). Retrieved 2005-03-20. This page is subject to change; the date reflects the last revision date.
- Crestor web site
- Rosuvastatin Information, site run by AstraZeneca
- Crestor/Rosuvastatin Fact Sheet
- Rosuvastatin (Crestor) Information
- Possible Crestor Side Effects
FDA documents index
- 11 March 2005: Letter from FDA to Public Citizen informing of the denial of Public Citizen's 4 March 2004 Citizen's Petition
- 8 March 2005: Letter from FDA to AstraZeneca regarding "false or misleading claims regarding the superiority of Crestor".
- 2 March 2005: FDA Public Health Advisory on Crestor (rosuvastatin), patient and healthcare provider information updated
- 2 March 2005: Letter from FDA to AstraZeneca mandating changes to prescription labeling
- 21 December 2004: Letter from FDA to AstraZeneca regarding "false or misleading safety claims" in a print ad
- 4 November 2004: FDA Docket listing 2004P-0113, regarding Public Citizen's Citizens' Petition of 4 March 2004
- 15 September 2004: FDA Docket listing 2004P-0113, regarding Public Citizen's Citizens' Petition of 4 March 2004
- 1 September 2004: Letter from FDA to Public Citizen indicating that Public Citizen's 4 March 2004 Citizen's Petition is still under consideration.
- 4 June 2004: FDA Docket listing 2004P-0113, regarding Public Citizen's Citizens' Petition of 4 March 2004
- 18 May 2004: Letter from Public Citizen to FDA, update to Citizen's Petition of 4 March 2004
- 6 March 2004: FDA Docket listing 2004P-0113, regarding Public Citizen's Citizens' Petition of 4 March 2004
- 5 March 2004: Letter from FDA to Public Citizen acknowledging receipt of Citizen's Petition.
- 4 March 2004: Letter from Public Citizen to FDA petitioning for the immediate removal of Crestor from the market
- 12 August 2003: Letter from FDA to AstraZeneca, approval letter
- 9 July 2003: Presentations to the Endocrinologoc (sic) and Metabolic Drugs Advisory Committee
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