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Volumn 66, Issue 7, 2012, Pages 571-572

Withdrawal of 'Xigris' from the market: Old and new lessons

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; DROTRECOGIN; PROTEIN C; RECOMBINANT PROTEIN;

EID: 84864020814     PISSN: 0143005X     EISSN: 14702738     Source Type: Journal    
DOI: 10.1136/jech-2012-200977     Document Type: Editorial
Times cited : (11)

References (14)
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    • Meeting on Xigris approval transcriptions, 2001. (accessed Feb 2012).
    • US Food and Drug Administration. Center for Drug Evaluation and Research. Anti-Infective drug Advisory Committee. Meeting on Xigris approval transcriptions, 2001. http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Anti-Infective (accessed Feb 2012).
    • Anti-Infective drug Advisory Committee
  • 2
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    • Errors in the approval process and post-marketing evaluation of drotrecogin alfa (activated) for the treatment of severe sepsis
    • Poole D, Bertolini G, Garattini S. Errors in the approval process and post-marketing evaluation of drotrecogin alfa (activated) for the treatment of severe sepsis. Lancet Infect Dis 2009;9:67-72.
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    • Poole, D.1    Bertolini, G.2    Garattini, S.3
  • 3
    • 8544268686 scopus 로고    scopus 로고
    • The effect of drotrecogin alfa (activated) on long-term survival after severe sepsis
    • Angus DC, Laterre PF, Helterbrand J, et al. The effect of drotrecogin alfa (activated) on long-term survival after severe sepsis. Crit Care Med 2004;32:2199-206.
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    • Angus, D.C.1    Laterre, P.F.2    Helterbrand, J.3
  • 4
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    • Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death
    • Abraham E, Laterre PF, Garg R, et al. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med 2005;353:1332-41.
    • (2005) N Engl J Med , vol.353 , pp. 1332-1341
    • Abraham, E.1    Laterre, P.F.2    Garg, R.3
  • 5
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    • Surviving sepsis campaign guidelines for management of severe sepsis and septic shock
    • Dellinger RP, Carlet JM, Masur H, et al. Surviving sepsis campaign guidelines for management of severe sepsis and septic shock. Intensive Care Med 2004;30:536-55.
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    • Dellinger, R.P.1    Carlet, J.M.2    Masur, H.3
  • 6
    • 33847361454 scopus 로고    scopus 로고
    • Use of Drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey
    • Bertolini G, Rossi C, Anghileri A, et al. Use of Drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey. Intensive Care Med 2007;33:426-34.
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    • Bertolini, G.1    Rossi, C.2    Anghileri, A.3
  • 7
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    • Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2008
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  • 8
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    • (accessed Nov).
    • EMA. Xigris (Drotrecogin Alfa (Activated)) to be Withdrawn Due to Lack of Efficacy. http://www.ema.europa.eu/ema/index.jsp?curl1/4pages/news_and_events/news/2011/2010/news_detail_001373.jsp&mid1/4WC001370b001301ac058004d001375c001371&murl1/4menus/news_and_events/news_and_events.jsp (accessed Nov 2011).
    • (2011) EMA. Xigris (Drotrecogin Alfa (Activated)) to be Withdrawn Due to Lack of Efficacy
  • 9
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    • Efficacy and safety of recombinant human activated protein C for severe sepsis
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    • Bernard, G.R.1    Vincent, J.L.2    Laterre, P.F.3
  • 10
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    • US Food and Drug Administration
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    • US Food and Drug Administration. Drotrecogin Alpha (Activated), Xigris. BLA # 125029/0. FDA Clinical Review. 2001. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/UCM113438.pdf (accessed Feb 2012).
    • (2001) Drotrecogin Alpha (Activated), Xigris
  • 11
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    • (2008) Crit Care Med , vol.36 , pp. 1105-1113
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  • 12
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.