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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761122
Company: GLAXOSMITHKLINE

Products on BLA 761122

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUCALA	MEPOLIZUMAB	100MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/06/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761122Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761122Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125526Orig1s021;761122Orig1s011Corrected_ltr.pdf
01/22/2022	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125526Orig1s019; 761122Orig1s008ltr.pdf
07/29/2021	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761122Orig1s006; 125526Orig1s018ltr.pdf
09/25/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761122s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761122Orig1s005ltr.pdf
09/12/2019	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf
09/12/2019	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf

Labels for BLA 761122

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf
01/22/2022	SUPPL-8	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf
07/29/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf
09/25/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761122s005lbl.pdf
09/12/2019	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf
09/12/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf
09/12/2019	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf
06/06/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf

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