FDA Approval for VEMLIDY issued to GILEAD SCIENCES INC
$GILD
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 208464
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| 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 |
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 |
| 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 |
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 |