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Heplisav Approval Status

  • FDA approved: No
  • Brand name: Heplisav
  • Generic name: hepatitis b adult vaccine
  • Company: Dynavax Technologies Corporation
  • Treatment for: Hepatitis B Prevention

Heplisav (hepatitis b adult vaccine) is an investigational vaccine intended for use in the immunization against infection caused by all known subtypes of hepatitis B virus.

In February 2013, Dynavax Technologies Corporation announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Heplisav had not been approved.

Development Status and FDA Approval Process for Heplisav

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

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