🇺🇸 Botulinum toxin A "Botox Cosmetics" in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Botulinum toxin A "Botox Cosmetics" on 9 December 1991

Marketing authorisation

FDA — authorised 9 December 1991

Application: BLA103000
Marketing authorisation holder: ALLERGAN
Status: supplemented

Frequently asked questions

Is Botulinum toxin A "Botox Cosmetics" approved in United States?

Yes. FDA authorised it on 9 December 1991.

Who is the marketing authorisation holder for Botulinum toxin A "Botox Cosmetics" in United States?

ALLERGAN holds the US marketing authorisation.