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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213217
Company: BEIGENE

Products on NDA 213217

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRUKINSA	ZANUBRUTINIB	80MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213217

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213217Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213217Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2024	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213217Orig1s011ltr.pdf
04/21/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s010ltr.pdf
12/21/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s009ltr.pdf
01/19/2023	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s007ltr.pdf
09/14/2021	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213217Orig1s005ltr.pdf
08/31/2021	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213217Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213217Orig1s004.pdf

Labels for NDA 213217

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2024	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217s011lbl.pdf
12/21/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217Orig1s009lbl.pdf
04/21/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s010lbl.pdf
01/19/2023	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s007lbl.pdf
09/14/2021	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s005lbl.pdf
08/31/2021	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s004lbl.pdf
11/14/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s000lbl.pdf

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