🇺🇸 Stelara in United States

Stelara (Stelara) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Stelara in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Stelara approved in United States?

Yes. FDA has authorised it.

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

Biocon Biologics UK Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.