FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC
$GILD
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 210251
Company: GILEAD SCIENCES INC
Company: GILEAD SCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | EQ 50MG BASE;200MG;EQ 25MG BASE | TABLET;ORAL | Prescription | None | Yes | Yes |
| BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | EQ 30MG BASE;120MG;EQ 15MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/07/2018 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210251Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210251Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/08/2024 | SUPPL-20 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251Orig1s020lbl.pdf | ||
| 04/24/2024 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210251Orig1s019ltr.pdf | |
| 02/23/2024 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210251Orig1s018ltr.pdf | |
| 05/01/2023 | SUPPL-17 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210251Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210251Orig1s017ltr.pdf | |
| 10/14/2022 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210251s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210251Orig1s015ltr.pdf | |
| 10/07/2021 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s014ltr.pdf | |
| 09/10/2021 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s013ltr.pdf | |
| 03/04/2021 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s010ltr.pdf | |
| 02/11/2021 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s009ltr.pdf | |
| 02/24/2021 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s008ltr.pdf | |
| 02/05/2021 | SUPPL-7 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s007ltr.pdf | |
| 08/02/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210251Orig1s006ltr.pdf | |
| 06/18/2019 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210251Orig1s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/08/2024 | SUPPL-20 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251Orig1s020lbl.pdf | |
| 04/24/2024 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s019lbl.pdf | |
| 02/23/2024 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s018lbl.pdf | |
| 05/01/2023 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210251Orig1s017lbl.pdf | |
| 10/14/2022 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210251s015lbl.pdf | |
| 10/07/2021 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s014lbl.pdf | |
| 09/10/2021 | SUPPL-13 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf | |
| 09/10/2021 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf | |
| 03/04/2021 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s010lbl.pdf | |
| 02/24/2021 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s008lbl.pdf | |
| 02/11/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf | |
| 02/11/2021 | SUPPL-9 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf | |
| 02/05/2021 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s007lbl.pdf | |
| 08/02/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s006lbl.pdf | |
| 06/18/2019 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s005lbl.pdf | |
| 02/07/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf |