FDA — authorised 29 April 2015
- Marketing authorisation holder: KYTHERA BIOPHARMS
- Status: approved
🇺🇸 Kybella in United States
FDA authorised Kybella on 29 April 2015
Marketing authorisations
FDA — authorised 29 April 2015
- Application: NDA206333
- Marketing authorisation holder: ABBVIE
- Local brand name: KYBELLA
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Kybella in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Kybella approved in United States?
Yes. FDA authorised it on 29 April 2015; FDA authorised it on 29 April 2015.
Who is the marketing authorisation holder for Kybella in United States?
KYTHERA BIOPHARMS holds the US marketing authorisation.