HAVRIX
HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells.
Advisory Board:
There were no product-specific concerns that would have benefited from an advisory committee discussion.
Indications: For active immunization against disease caused by hepatitis A virus (HAV) for persons 12 months of age and older.
Key Regulatory Milestones:
07/24/2011 – PDUFA goal date
12/19/2018 – FDA approval date