🇺🇸 OM-85 in United States

OM-85 (OM-85) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

OM-85 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 OM-85 approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for OM-85 in United States?

OM Pharma SA is the originator. The local marketing authorisation holder may differ — check the official source linked above.