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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761065
Company: THERATECHNOLOGIES

Products on BLA 761065

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TROGARZO	IBALIZUMAB-UIYK	150MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761065

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/TROGARZO_761065_TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2023	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761065s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761065Orig1s020ltr.pdf
10/03/2022	SUPPL-13	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761065s013lbl.pdf
04/22/2021	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761065s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761065Orig1s011ltr.pdf
04/17/2020	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761065s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761065Orig1s008ltr.pdf
05/30/2018	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s001ltr.pdf

Labels for BLA 761065

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2023	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761065s020lbl.pdf
12/12/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761065s020lbl.pdf
10/03/2022	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761065s013lbl.pdf
04/22/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761065s011lbl.pdf
04/17/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761065s008lbl.pdf
04/17/2020	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761065s008lbl.pdf
05/30/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf
05/30/2018	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf
03/06/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf

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