🇺🇸 HEPLISAV in United States

HEPLISAV (HEPLISAV) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

HEPLISAV 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 HEPLISAV approved in United States?

Yes. FDA has authorised it.

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

Dynavax Technologies Corporation is the originator. The local marketing authorisation holder may differ — check the official source linked above.