Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209394
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MAVYRET | GLECAPREVIR; PIBRENTASVIR | 100MG;40MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
08/03/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209394Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209394_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209394Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/25/2023 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209394Orig1s016;215110Orig1s003ltr.pdf | |
09/28/2021 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s001;209394Orig1s014ltr.pdf | |
06/10/2021 | SUPPL-13 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s000; 209394Orig1s013ltr.pdf | |
04/10/2020 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209394s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209394Orig1s010ltr.pdf | |
09/26/2019 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209394Orig1s008ltr.pdf | |
09/26/2019 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209394Orig1s007ltr.pdf | |
04/30/2019 | SUPPL-6 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209394Orig1s006ltr.pdf | |
12/11/2017 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209394Orig1s003ltr.pdf | |
08/06/2018 | SUPPL-2 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209394s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209394Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/25/2023 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf | |
09/28/2021 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf | |
09/28/2021 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf | |
06/10/2021 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf | |
04/10/2020 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209394s010lbl.pdf | |
09/26/2019 | SUPPL-8 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s008lbl.pdf | |
09/26/2019 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s007lbl.pdf | |
04/30/2019 | SUPPL-6 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s006lbl.pdf | |
08/06/2018 | SUPPL-2 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209394s002lbl.pdf | |
12/11/2017 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s003lbl.pdf | |
08/03/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s000lbl.pdf |