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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761136
Company: CELGENE CORP

Products on BLA 761136

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REBLOZYL	LUSPATERCEPT-AAMT	25MG/VIAL	POWDER;SUBCUTANEOUS	Prescription	None	No	No
REBLOZYL	LUSPATERCEPT-AAMT	75MG/VIAL	POWDER;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2020	ORIG-2	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761136orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761136Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761136Orig2s000TOC.cfm
11/08/2019	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761136Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761136Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2023	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761136s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761136Orig1s009ltr.pdf
07/08/2022	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761136s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761136Orig1s006ltr.pdf

Labels for BLA 761136

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2023	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761136s009lbl.pdf
07/08/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761136s006lbl.pdf
07/08/2022	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761136s006lbl.pdf
04/03/2020	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761136orig2lbl.pdf
11/08/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761136lbl.pdf

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