🇺🇸 Recombinant FVIII in United States

Recombinant FVIII (Recombinant FVIII) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Recombinant FVIII 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 Recombinant FVIII approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Recombinant FVIII in United States?

Fondazione Angelo Bianchi Bonomi is the originator. The local marketing authorisation holder may differ — check the official source linked above.