🇺🇸 Amelogenin in United States

Amelogenin (Amelogenin) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Amelogenin 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 Amelogenin approved in United States?

Yes. FDA has authorised it.

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

University of Roma La Sapienza is the originator. The local marketing authorisation holder may differ — check the official source linked above.