🇺🇸 HULIO in United States

FDA authorised HULIO on 6 July 2020

Marketing authorisation

FDA — authorised 6 July 2020

Application: BLA761154
Marketing authorisation holder: MYLAN PHARMS INC
Local brand name: HULIO
Indication: INJECTABLE — INJECTION
Status: approved

Mylan Pharms Inc has been granted marketing authorisation by the FDA for HULIO. The approval was issued on 15 December 2023, following a standard expedited pathway. The marketing authorisation holder will be responsible for ensuring the safe and effective use of HULIO in the United States.

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HULIO 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 HULIO approved in United States?

Yes. FDA authorised it on 6 July 2020.

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

MYLAN PHARMS INC holds the US marketing authorisation.