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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761070
Company: ASTRAZENECA AB

Products on BLA 761070

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FASENRA	BENRALIZUMAB	30MG/ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761070

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2017	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761070Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761070Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2024	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761070Orig1s0021ltr.pdf
04/05/2024	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070Orig1s020correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761070Orig1s020correctedltr.pdf
10/03/2019	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761070s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761070Orig1s005ltr.pdf

Labels for BLA 761070

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2024	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf
04/05/2024	SUPPL-20	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070Orig1s020correctedlbl.pdf
10/03/2019	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761070s005lbl.pdf
10/03/2019	SUPPL-5	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761070s005lbl.pdf
10/03/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761070s005lbl.pdf
11/14/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf

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