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Dengvaxia FDA Approval History

Last updated by Judith Stewart, BPharm on July 24, 2023.

FDA Approved: Yes (First approved May 1, 2019)
Brand name: Dengvaxia
Generic name: dengue tetravalent vaccine, live
Dosage form: Injection
Company: Sanofi Pasteur, Inc.
Treatment for: Prevention of Dengue Disease

Dengvaxia (dengue tetravalent vaccine, live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Dengvaxia. Prescribing information. Sanofi Pasteur, Inc. 2023 Accessed July 24, 2023

Development timeline for Dengvaxia

May  1, 2019Approval FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
Oct 30, 2018FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.