Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761445
Company: SANOFI-AVENTIS U.S. LLC

Products on BLA 761445

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SARCLISA ESCENA	ISATUXIMAB-IRFC	1400MG/10ML (140MG/ML)	VIAL;SINGLE-DOSE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761445

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/2026	ORIG-1	Approval		N/A; Orphan	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761445Orig1s000Correctedltr.pdf