🇺🇸 REBYOTA™ in United States

REBYOTA™ (REBYOTA™) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

REBYOTA™ 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 REBYOTA™ approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for REBYOTA™ in United States?

Ferring Pharmaceuticals is the originator. The local marketing authorisation holder may differ — check the official source linked above.