🇺🇸 Group R in United States

Group R (Group R) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Group R 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 Group R approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Group R in United States?

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