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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761035
Company: BRISTOL MYERS SQUIBB

Summary Review

Products on BLA 761035

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMPLICITI	ELOTUZUMAB	300MG	INJECTABLE;INJECTION	Prescription	None	No	No
EMPLICITI	ELOTUZUMAB	400MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761035

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2015	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761035Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761035Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761035Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2022	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761035s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761035Orig1s015ltr.pdf
10/28/2019	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761035s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761035Orig1s010ltr.pdf
11/06/2018	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761035s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761035Orig1s008ltr.pdf
05/11/2017	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761035s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761035Orig1s005ltr.pdf

Labels for BLA 761035

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2022	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761035s015lbl.pdf
10/28/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761035s010lbl.pdf
11/06/2018	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761035s008lbl.pdf
05/11/2017	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761035s005lbl.pdf
11/30/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf

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