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Fat-reduction injectables

Kybella

AbbVie Inc.

FDA-approved drugChecked Sep 14, 2026 · Read on the pages cited

What it is

Maker
AbbVie Inc.
Category
Fat-reduction injectables
Also called
deoxycholic acid, KYBELLA

FDA status

Pathway
FDA-approved drug
First approved or cleared
2015

Research notes

Drugs@FDA original approval 2015-04-29 (new molecular entity). No boxed warning on the label.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Improvement in the appearance of moderate to severe fullness under the chin caused by submental fat, in adults
  • Limitation on the label: safety and effectiveness for fat outside the submental (under-chin) area have not been established

How it’s sold

Single-use 2 mL glass vials, 10 mg/mL solution

What the label warns about

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 NDA 206333, 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 NDA 206333 and a number from the box

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: NDA 206333 (KYBELLA) (opens in a new tab)FDA database
  2. DailyMed: KYBELLA prescribing information (revised 10/2024) (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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