🇺🇸 Filsuvez in United States

Filsuvez (birch bark extract) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Filsuvez in other countries

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

Other Dermatology approved in United States

Frequently asked questions

Is Filsuvez approved in United States?

Yes. FDA has authorised it.

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

Amryt Pharmaceuticals Dac is the originator. The local marketing authorisation holder may differ — check the official source linked above.