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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761103
Company: PFIZER INC

Medication Guide

Products on BLA 761103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RUXIENCE	RITUXIMAB-PVVR	100MG/10ML(10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No
RUXIENCE	RITUXIMAB-PVVR	500MG/50ML(10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761103Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2021	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761103s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761103Orig1s005ltr.pdf
05/26/2020	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761103Orig1s003ltr.pdf

Labels for BLA 761103

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2021	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761103s005lbl.pdf
05/26/2020	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf
07/23/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf

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