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
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