Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208772
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALUNBRIG | BRIGATINIB | 30MG | TABLET;ORAL | Prescription | None | Yes | No |
ALUNBRIG | BRIGATINIB | 90MG | TABLET;ORAL | Prescription | None | Yes | No |
ALUNBRIG | BRIGATINIB | 180MG | 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 |
---|---|---|---|---|---|---|---|
04/28/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208772Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208772Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/28/2022 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208772Orig1s013ltr.pdf | |
09/24/2021 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208772s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208772Orig1s012ltr.pdf | |
05/22/2020 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208772s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208772Orig1s008ltr.pdf | |
12/21/2018 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208772s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208772Orig1s004Ltr.pdf | |
10/02/2017 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/28/2022 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf | |
02/28/2022 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf | |
09/24/2021 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208772s012lbl.pdf | |
09/24/2021 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208772s012lbl.pdf | |
05/22/2020 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208772s008lbl.pdf | |
12/21/2018 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208772s004lbl.pdf | |
04/28/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf |