🇺🇸 Orgalutran® in United States

Orgalutran® (Orgalutran®) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Orgalutran® in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Orgalutran® approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Orgalutran® in United States?

University Hospital, Ghent is the originator. The local marketing authorisation holder may differ — check the official source linked above.