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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761121
Company: GENENTECH

Products on BLA 761121

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POLIVY	POLATUZUMAB VEDOTIN-PIIQ	140MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	No	No
POLIVY	POLATUZUMAB VEDOTIN-PIIQ	30MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761121

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2019	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761121Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761121Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2023	SUPPL-8	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761121s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761121Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761121Orig1s008TOC.cfm
09/18/2020	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761121Orig1s003ltr.pdf

Labels for BLA 761121

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2023	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761121s008lbl.pdf
09/18/2020	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121Orig1s003lbl.pdf
06/10/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s000lbl.pdf

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