Rosuvastatin chemical structure

Presentation

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.

Rosuvastatin is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of action similar to other statins.

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.

Notes

1. 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.
2. ⇧ ibid.
3. ⇧ The Food and Drug Administration (August 12, 2003). FDA Approves New Drug for Lowering Cholesterol. Press Release. Retrieved 2005-03-20.
4. ⇧ 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.
5. ⇧ 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.

External links

• Crestor web site
• Rosuvastatin Information, site run by AstraZeneca
• Crestor/Rosuvastatin Fact Sheet
• Rosuvastatin (Crestor) Information
• Possible Crestor Side Effects

FDA documents index

2005

• 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

2004

• 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

2003

• 12 August 2003: Letter from FDA to AstraZeneca, approval letter
• 9 July 2003: Presentations to the Endocrinologoc (sic) and Metabolic Drugs Advisory Committee