Proper Name: Hepatitis B Vaccine (Recombinant), Adjuvanted
Manufacturer: Dynavax Technologies Corporation
- For prevention of infection caused by all known subtypes of hepatitis B virus. HEPLISAV-B is approved for use in adults 18 years of age and older.
- Package Insert - HEPLISAV-B
- Demographic Subgroup Information - Hepatitis B Vaccine (Recombinant), Adjuvanted; HEPLISAV-B
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- May 6, 2020 Approval Letter - HEPLISAV-B
- March 22, 2018 Approval Letter - HEPLISAV-B
- November 9, 2017 Approval Letter - HEPLISAV-B
- November 9, 2017 Summary Basis for Regulatory Action - HEPLISAV-B
- OVRR and OBE Office Directors' Memo
- Approval History, Letters, Reviews, and Related Documents - HEPLISAV-B