FDA Approval for VEKLURY issued to GILEAD SCIENCES INC
$GILD
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 214787
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VEKLURY | REMDESIVIR | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | Yes | Yes |
| VEKLURY | REMDESIVIR | 100MG/20ML (5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 10/22/2020 | 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/2020/214787Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214787Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000Sumr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/27/2024 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2024 | SUPPL-26 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214787s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214787Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2024/214787Orig1s026SumR.pdf | |
| 08/17/2023 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s025ltr.pdf | |
| 08/23/2023 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s024ltr.pdf | |
| 06/07/2023 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787orig1s023ltr.pdf | |
| 04/28/2023 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s022ltr.pdf | |
| 06/12/2023 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s021ltr.pdf | |
| 12/15/2022 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s020ltr.pdf | |
| 07/13/2023 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s019ltr.pdf | |
| 03/29/2023 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214787Orig1s018ltr.pdf | |
| 10/24/2022 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s016ltr.pdf | |
| 06/24/2022 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s015ltr.pdf | |
| 09/29/2022 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s014ltr.pdf | |
| 03/24/2022 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s013ltr.pdf | |
| 04/25/2022 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s011.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s011JointReview.pdf | |
| 01/21/2022 | SUPPL-10 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s010Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s010.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214787Orig1s010JointReview.pdf | |
| 01/19/2022 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214787Orig1s009ltr.pdf | |
| 02/22/2021 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214787s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214787Orig1s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2024 | SUPPL-26 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214787s026lbl.pdf | |
| 08/23/2023 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s024lbl.pdf | |
| 08/17/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s025lbl.pdf | |
| 07/13/2023 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s019lbl.pdf | |
| 06/12/2023 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s021lbl.pdf | |
| 06/07/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s023lbl.pdf | |
| 04/28/2023 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s022lbl.pdf | |
| 03/29/2023 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214787s018lbl.pdf | |
| 12/15/2022 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s020lbl.pdf | |
| 10/24/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s016lbl.pdf | |
| 09/29/2022 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s014lbl.pdf | |
| 06/24/2022 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s015lbl.pdf | |
| 04/25/2022 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s011lbl.pdf | |
| 03/24/2022 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s013lbl.pdf | |
| 01/21/2022 | SUPPL-10 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787Orig1s010Lbl.pdf | |
| 01/19/2022 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s009lbl.pdf | |
| 02/22/2021 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214787s005lbl.pdf | |
| 10/22/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf |