Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761170
Company: GENENTECH INC

Products on BLA 761170

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHESGO	PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF	1,200MG;600MG;30,000UNITS	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
PHESGO	PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF	600MG;600MG;20,000UNITS	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761170

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761170Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761170Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2024	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761170s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761170Orig1s007ltr.pdf

Labels for BLA 761170

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2024	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761170s007lbl.pdf
06/29/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf