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    FDA Approval for JAKAFI issued to INCYTE CORP

    9/23/21 5:11:12 AM ET
    $INCY
    Biotechnology: Commercial Physical & Biological Resarch
    Health Care
    Get the next $INCY alert in real time by email
    New Drug Application (NDA): 202192
    Company: INCYTE CORP
    • Email
    • Summary Review

    Products on NDA 202192

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    JAKAFI RUXOLITINIB PHOSPHATE EQ 5MG BASE TABLET;ORAL Prescription None Yes No
    JAKAFI RUXOLITINIB PHOSPHATE EQ 10MG BASE TABLET;ORAL Prescription None Yes No
    JAKAFI RUXOLITINIB PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription None Yes No
    JAKAFI RUXOLITINIB PHOSPHATE EQ 20MG BASE TABLET;ORAL Prescription None Yes No
    JAKAFI RUXOLITINIB PHOSPHATE EQ 25MG BASE TABLET;ORAL Prescription None Yes Yes

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 202192

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    11/16/2011 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
    Letter (PDF)
    Review
    Summary Review (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202192s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000SumR.pdf
    Supplements
    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
    09/22/2021 SUPPL-23 Efficacy-New Indication

    Label is not available on this site.

    01/14/2020 SUPPL-19 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202192Orig1s019Rpllbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202192Orig1s019ltr.pdf
    05/24/2019 SUPPL-17 Efficacy-New Indication Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202192Orig1s017ltr.pdf
    10/26/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202192s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202192Orig1s016ltr.pdf
    12/06/2017 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s015ltr.pdf
    10/10/2017 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s014ltr.pdf
    03/10/2016 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202192Orig1s012ltr.pdf
    10/06/2015 SUPPL-11 Manufacturing (CMC)

    Label is not available on this site.

    12/02/2015 SUPPL-10 Manufacturing (CMC)

    Label is not available on this site.

    12/15/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s009ltr.pdf
    12/04/2014 SUPPL-8 Efficacy-New Indication Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s008ltr.pdf
    05/30/2014 SUPPL-7 Manufacturing (CMC)

    Label is not available on this site.

    07/25/2014 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s006ltr.pdf
    11/25/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s005ltr.pdf
    11/07/2013 SUPPL-4 Manufacturing (CMC)

    Label is not available on this site.

    06/12/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s003ltr.pdf
    06/21/2012 SUPPL-1 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202192s001ltr.pdf

    Labels for NDA 202192

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    01/14/2020 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202192Orig1s019Rpllbl.pdf
    05/24/2019 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf
    10/26/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202192s016lbl.pdf
    12/06/2017 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf
    12/06/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf
    10/10/2017 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf
    03/10/2016 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf
    12/15/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf
    12/04/2014 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf
    07/25/2014 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf
    11/25/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf
    06/12/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf
    06/21/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf
    11/16/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf
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