🇺🇸 Isatuximab SC in United States

Isatuximab SC (isatuximab-sc) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Isatuximab SC 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 Isatuximab SC approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Isatuximab SC in United States?

Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.