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Heplisav-B FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved November 10, 2017)
Brand name: Heplisav-B
Generic name: hepatitis B vaccine, recombinant (adjuvanted)
Dosage form: Injection
Company: Dynavax Technologies Corporation
Treatment for: Hepatitis B Prevention

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) is a vaccine for use in the immunization against infection caused by all known subtypes of hepatitis B virus.

Development timeline for Heplisav-B

Nov  9, 2017Approval Dynavax Announces FDA Approval of Heplisav-B for Prevention of Hepatitis B in Adults
Aug  3, 2017Dynavax Provides U.S. Regulatory Update on Heplisav-B Following FDA Advisory Committee Meeting
Jul 28, 2017Dynavax Announces FDA Advisory Committee Vote in Favor of Heplisav-B
Nov 14, 2016Dynavax Receives Complete Response Letter from U.S. FDA for Biologics License Application for Heplisav-B
Oct  4, 2016Dynavax Provides Regulatory Update on Heplisav-B
Jun 10, 2013Dynavax Reports Feedback From FDA Meeting Regarding Heplisav Biologic License Application
Feb 25, 2013Dynavax Receives FDA Complete Response Letter on Heplisav Biologic License Application
Nov 16, 2012Dynavax Announces FDA Advisory Committee Meeting Outcome for Heplisav
Aug 29, 2012Dynavax Announces FDA Advisory Committee to Review Heplisav
Jun 27, 2012Dynavax Announces FDA Acceptance of Heplisav BLA
Apr 27, 2012Dynavax Reports Heplisav BLA Submission

Further information

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