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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125349
Company: HUMAN GENOME SCIENCES INC.

Summary Review

Products on BLA 125349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAXIBACUMAB	RAXIBACUMAB	1700MG/34ML (50MG/ML)	INJECTABLE; IV (INFUSION)	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2012	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125349Orig1s000ltr(r).pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2021	SUPPL-26	Supplement	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125349s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125349Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125349Orig1s026ltr.pdf
01/11/2018	SUPPL-22	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125349s022lbl.pdf

Labels for BLA 125349

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2021	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125349s026lbl.pdf
01/11/2018	SUPPL-22	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125349s022lbl.pdf
12/14/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125349s000lbl.pdf

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