🇺🇸 Naltexone in United States

Naltexone (Naltexone) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Naltexone 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 Naltexone approved in United States?

Yes. FDA has authorised it.

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

Finnish Institute for Health and Welfare is the originator. The local marketing authorisation holder may differ — check the official source linked above.