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Neurotoxins

Jeuveau

Evolus, Inc. (manufactured by Daewoong Pharmaceutical Co., Ltd.)

Licensed biologic (FDA)Checked Sep 14, 2026 · Read on the pages cited

What it is

Maker
Evolus, Inc. (manufactured by Daewoong Pharmaceutical Co., Ltd.)
Category
Neurotoxins
Also called
prabotulinumtoxinA-xvfs, JEUVEAU, Newtox

FDA status

Pathway
Licensed biologic (FDA)
First approved or cleared
2019

Research notes

Drugs@FDA original approval date 2019-02-01. The alias 'Newtox' comes from the site's catalogue and was not found on an FDA page.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Temporary improvement in the appearance of moderate to severe glabellar (frown) lines in adults

How it’s sold

Units; single-dose vial of 100 Units of vacuum-dried powder that is reconstituted before injection

Not interchangeable

The label states: "Potency Units of JEUVEAU are not interchangeable with other preparations of botulinum toxin products."

What the label warns about

  • Boxed warning (Distant Spread of Toxin Effect): toxin effects can spread beyond the injection site.

    “The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.”

    Source: DailyMed: JEUVEAU prescribing information (opens in a new tab)

Checking it’s the real thing

No FDA authenticity notice is recorded for this product.

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under BLA 761085, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up BLA 761085 and a number from the box

What changed at the source

Dated FDA records that concern Jeuveau, newest first. A record says what happened at the source; it is not a finding about any clinic's stock.

  1. Enforcement or recall ·

    FDA warned 18 websites selling unapproved botulinum toxin

    U.S. Food & Drug Administration · FDA news release, 2025-11-05

    FDA issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, and restated that FDA-approved botulinum toxin products are available only with a prescription and should come from an authorized source.

    What this source establishes
    That FDA acted against specific websites selling unapproved or misbranded botulinum toxin, and that approved products are prescription-only.
    What it does not establish
    Whether a particular clinic's vial is genuine or where it was bought. The carton, the vial and the practice's supplier are what speak to that.

    The official record (opens in a new tab) · checked Sep 25, 2026

Check it yourself

Injectable drug proof ladder: The service uses botulinum toxin or another named prescription drug. Work down in order — each step needs the one before it.

  1. Read carton and vialRecord brand, active ingredient, strength, lot, and expiration rather than a menu nickname.
  2. Confirm approvalSearch the exact drug in Drugs@FDA.Drugs@FDA (opens in a new tab) · U.S. Food & Drug Administration
  3. Read current labelingUse DailyMed for current package and prescribing information.DailyMed (opens in a new tab) · U.S. National Library of Medicine
  4. Confirm sourceAsk how the practice sourced the product and whether the manufacturer recognizes that supply channel.
  5. Verify injectorCheck the named injector against the issuing board; do not infer a credential from a website title.
  6. Name escalationGet the after-hours complication contact before the procedure, not after a problem occurs.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. Drugs@FDA: BLA 761085 (JEUVEAU) (opens in a new tab)FDA database
  2. DailyMed: JEUVEAU prescribing information (opens in a new tab)Label

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

Product identity

Told a name? Shown a box?

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