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