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    FDA Approval for VEMLIDY issued to GILEAD SCIENCES INC

    3/27/24 1:12:04 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $GILD alert in real time by email
    New Drug Application (NDA): 208464
    Company: GILEAD SCIENCES INC
    • Email

    Products on NDA 208464

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    VEMLIDY TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription AB Yes Yes

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 208464

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    11/10/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
    Letter (PDF)
    Review
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208464s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208464Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208464Orig1s000TOC.cfm
    Supplements
    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
    03/27/2024 SUPPL-17

    Label is not available on this site.

    03/27/2024 SUPPL-16

    Label is not available on this site.

    12/14/2022 SUPPL-15 Manufacturing (CMC)-Facility Letter (PDF)

    Label is not available on this site.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208464Orig1s015Corrected_ltr.pdf
    10/17/2022 SUPPL-14 Efficacy-New Patient Population Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208464s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208464Orig1s014ltr.pdf
    09/15/2021 SUPPL-13 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208464Orig1s013ltr.pdf
    03/04/2021 SUPPL-12 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208464Orig1s012ltr.pdf
    08/18/2020 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s010,s011ltr.pdf
    08/18/2020 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s010,s011ltr.pdf
    02/04/2020 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208464Orig1s008ltr.pdf
    02/04/2019 SUPPL-7 Efficacy-New Patient Population Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208464s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208464Orig1s007ltr.pdf
    07/03/2018 SUPPL-4 Efficacy-Labeling Change With Clinical Data Letter (PDF)

    Label is not available on this site.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208464Orig1s004ltr.pdf
    04/07/2017 SUPPL-1 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208464s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208464Orig1s001ltr.pdf

    Labels for NDA 208464

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    10/17/2022 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208464s014lbl.pdf
    09/15/2021 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s013lbl.pdf
    03/04/2021 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208464s012lbl.pdf
    08/18/2020 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf
    08/18/2020 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s010s011lbl.pdf
    02/04/2020 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208464s008lbl.pdf
    02/04/2019 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208464s007lbl.pdf
    04/07/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208464s001lbl.pdf
    11/10/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208464s000lbl.pdf

    Therapeutic Equivalents for NDA 208464

    VEMLIDY

    TABLET;ORAL; EQ 25MG BASE
    TE Code = AB

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
    TENOFOVIR ALAFENAMIDE TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 214226 LUPIN LTD
    TENOFOVIR ALAFENAMIDE FUMARATE TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription No AB 213867 APOTEX
    VEMLIDY TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 208464 GILEAD SCIENCES INC
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