🇺🇸 pirfenidone and nintedanib in United States

pirfenidone and nintedanib (pirfenidone and nintedanib) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

pirfenidone and nintedanib 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 pirfenidone and nintedanib approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for pirfenidone and nintedanib in United States?

Hospices Civils de Lyon is the originator. The local marketing authorisation holder may differ — check the official source linked above.