Weighing benefits and risks - The FDA's review of prasugrel

New England Journal of Medicine

Volumn 361, Issue 10, 2009, Pages 942-945

  Unger, Ellis F ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; PRASUGREL;

ACUTE CORONARY SYNDROME; BLEEDING; CLINICAL TRIAL; DRUG EFFICACY; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; HEART INFARCTION; HUMAN; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SHORT SURVEY; THROMBOCYTE AGGREGATION INHIBITION; TUMOR GROWTH; UNSTABLE ANGINA PECTORIS;

EID: 69949163560     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp0907122     Document Type: Article

References (4)

1. Food and Drug Administration. FDA approved drug products. (Accessed August 13, 2009, at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index. cfm?fuseaction=Search.Label-ApprovalHistory#apphist.)
2. Food and Drug Administration Center for Drug Evaluation and Research Cardiovascular and Renal Drugs Advisory Committee. Prasugrel for reduction of cardiovascular events in patients with acute coronary syndrome (ACS). (Accessed August 13, 2009, at http://www.fda.gov/downloads/Advisory Committees/ CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisory Committee/UCM136141.pdf.)
3. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007;357:2001-2015 (Pubitemid 350106708)
4. Antman EM, Wiviott SD, Murphy SA, et al. Early and late benefits of prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel- Thrombolysis In Myocardial Infarction) analysis. J Am Coll Cardiol 2008;51:2028-2033