🇺🇸 Group S in United States

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

Marketing authorisation

FDA

  • Status: approved

Group S 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 S approved in United States?

Yes. FDA has authorised it.

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

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