اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BIKTARVY از شرکت GILEAD SCIENCES INC
New Drug Application (NDA): 210251
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 |
TBD |
TBD | 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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/2021 | SUPPL-14 | Efficacy-New Patient Population |
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 |
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 |
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-Patient Package Insert, Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 10/07/2021 | 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-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf | |
| 02/11/2021 | SUPPL-9 |
Labeling-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 |
BIKTARVY
There are no Therapeutic Equivalents.
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