Product Approval Information
Proper Name: Smallpox Vaccine, Dried, Calf Lymph Type
Tradename: Dryvax
Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003
Package Insert (PDF 749 KB) - October, 2007
Date: October 2, 2007
Labeling Supplement: Include additional language regarding skin lesions at the smallpox vaccination site
October 2, 2007 Approval Letter
Date: October 11, 2005
Labeling Supplement: New Black Box warning for cardiac events and other safety information
October 11, 2005 Approval Letter
Date: November 5, 2004
Labeling Supplement: Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults
November 5, 2004 Approval Letter
Date: June 26, 2003
Labeling Supplement: New safety information for the recent reports of cardiac events and updated storage period for the vaccine after reconstitution from 15 days to 90 days
June 26, 2003 Approval Letter
Date: October 25, 2002
Indication: Active immunization against smallpox disease
October 25, 2002 Approval Letter
Women with Smallpox Vaccine Exposure During Pregnancy Reported to the National Smallpox Vaccine in Pregnancy Registry --- United States, 2003 - MMWR - 5/2/2003
Frequently Asked Questions
FDA Announces Smallpox Vaccine Guidance for Blood Industry - 12/30/2002
Questions and Answers on FDA Guidance
Smallpox Information Page