Proper Name
Hepatitis A Vaccine, Inactivated
Indication
For the prevention of disease cause by hepatitis A virus (HAV) in persons 12 months of age and older.
Description
VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts.
Key Regulatory Milestones
1996 - VAQTA licensed in the U.S.
07/19/2012 - PDUFA goal date
10/23/2020 - FDA approval date
Advisory Committee
There were no product-specific concerns that would have benefited from an advisory committee discussion.
Package Insert
Advanced Facts