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Brand-name prescription medicine

Sarclisa Escena

Generic name: Isatuximab

FDA application holder: Sanofi-Aventis U.S. LLC

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

1Strengths and forms
0Same medicine, other names
2026FDA approval
0Recalls (FDA reports)

Quick answers

What is Sarclisa Escena?
Sarclisa Escena is a brand name of Isatuximab, a prescription medicine. The FDA NDC Directory lists 1 Sarclisa Escena product in 1 strength and form.
Who makes Sarclisa Escena?
Sanofi-Aventis U.S. LLC holds the FDA application for Sarclisa Escena (BLA761445, approved July 9, 2026).
Is there a generic or store brand of Sarclisa Escena?
Other products of Isatuximab are listed with the FDA, but none in exactly the same strength and form as a Sarclisa Escena product.
Has Sarclisa Escena been recalled?
No recall linked to Sarclisa Escena products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Sarclisa Escena is

Each Sarclisa Escena product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Isatuximab · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
isatuximab 140 mg/mL
injection, solution (subcutaneous)		 Sarclisa Escena None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Isatuximab →

FDA approval

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
FDA applications of Sarclisa Escena products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
BLA761445Sanofi-Aventis U.S. LLCJuly 9, 20261

Companies that list Sarclisa Escena

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Sarclisa Escena products.

Recalls

No recall linked to Sarclisa Escena products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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