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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208772
Company: TAKEDA PHARMS USA

Products on NDA 208772

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208772

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	Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data	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-Patient Package Insert, Labeling-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.

Labels for NDA 208772

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf
02/28/2022	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf
09/24/2021	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208772s012lbl.pdf
09/24/2021	SUPPL-12	Labeling-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

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