🇺🇸 SAMe in United States

SAMe (SAMe) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

SAMe in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is SAMe approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for SAMe in United States?

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