🇺🇸 OTULFI in United States

FDA authorised OTULFI on 27 September 2024

Marketing authorisation

FDA — authorised 27 September 2024

Application: BLA761379
Marketing authorisation holder: FRESENIUS KABI USA
Local brand name: OTULFI
Indication: INJECTABLE — INJECTION
Status: approved

The FDA granted marketing authorisation to OTULFI for its approved indication on 14 August 2025. The marketing authorisation holder is FRESENIUS KABI USA. The application number for this approval is BLA761379. OTULFI was approved through the standard expedited pathway.

Read official source →

OTULFI 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 OTULFI approved in United States?

Yes. FDA authorised it on 27 September 2024.

Who is the marketing authorisation holder for OTULFI in United States?

FRESENIUS KABI USA holds the US marketing authorisation.