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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761115
Company: IMMUNOMEDICS INC

Products on BLA 761115

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRODELVY	SACITUZUMAB GOVITECAN-HZIY	180MG	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761115

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761115Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761115Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2023	SUPPL-36	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761115Orig1s036ltr.pdf
02/03/2023	SUPPL-35	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761115Orig1s035ltr.pdf
12/05/2022	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115Orig1s031Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761115Orig1s031ltr.pdf
06/03/2022	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761115Orig1s023ltr.pdf
04/07/2021	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s005, s013ltr.pdf
04/13/2021	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s009ltr.pdf
04/07/2021	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s005, s013ltr.pdf

Labels for BLA 761115

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2023	SUPPL-35	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf
12/05/2022	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115Orig1s031Lbl.pdf
06/03/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115s023lbl.pdf
04/13/2021	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf
04/07/2021	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf
04/07/2021	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf
04/22/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf

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