Pharmaceutical & Health Technology

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  • 1.  old PIs not at the FDA website

    Posted 01-06-2022 15:41
    Hi all,

    Besides Drug@FDA, does anyone know of a source for obtaining old Prescribing Information aka Package Inserts? Better still, can anyone provide a PDF of the 1989 PI (1st approval) for Clozaril (clozapine). The was NDA 19-758.

    Happy New Year
    Mark

    ------------------------------
    Mark Domke
    Research Specialist
    Prescott Medical Communications
    (312) 528-3913
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  • 2.  RE: old PIs not at the FDA website

    Posted 01-06-2022 15:59
    Happy New Year, Mark!

    Have you tried out DailyMed? DailyMed is produced by NLM and even the FDA refers folks to DailyMed. When pulling up a monograph, you should be able to see the section for labelling archives to pull up older labels.

    DailyMed (nih.gov)

    Besides DailyMed, you may find DrugBank useful. DrugBank is produced by OMx Personal Health Analytics Inc; started out of University of Alberta.

    Hope that helps!

    Stay safe & Cheers,

    Chrissy


    ------------------------------
    She/Her/Hers/Herself
    Christine (Chrissy) Geluk, M.S.L.I.S.
    Principal & Founder
    Librarian At Your Service LLC
    support@librarianatyourservice.com | Chrissy@librarianatyourservice.com | Twitter @cmgeluk | Instagram @cgeluk
    ------------------------------



  • 3.  RE: old PIs not at the FDA website

    Posted 01-06-2022 16:50
    Thanks Chrissy! I didn't know about the Label Archive, so yes, that helps. For this drug it had records back to 2008. No dice at Drugbank but thanks for that too. I got a copy of the approved FDA labeling and FDA letter from FOI Services.

    Best
    Mark Domke

    Senior Research Specialist, MLIS
    Prescott Medical Communications Group
    10 S LaSalle St,  Suite 2400
    Chicago, IL 60603
    www.pmcg.agency



    ------------------------------
    Mark Domke
    Research Specialist
    Prescott Medical Communications
    (312) 528-3913
    ------------------------------



  • 4.  RE: old PIs not at the FDA website

    Posted 01-06-2022 17:13
    You're welcome, Mark! Yay! Marlene & her team to the rescue 😉😊

    Stay safe & Cheers,

    Chrissy

    ------------------------------
    She/Her/Hers/Herself
    Christine (Chrissy) Geluk, M.S.L.I.S.
    Principal & Founder
    Librarian At Your Service LLC
    support@librarianatyourservice.com | Chrissy@librarianatyourservice.com | Twitter @cmgeluk | Instagram @cgeluk
    ------------------------------