Vaccines, Blood & Biologics
The documents for Dryvax has been removed from the site because the license for Wyeth Pharmaceuticals, Inc., smallpox vaccine (Dryvax) was revoked (6/18/2009). The firm requested the voluntary revocation.
October 2, 2007 Approval Letter - Dryvax
To include additional language regarding skin lesions at the smallpox vaccination site.
October 11, 2005 Approval Letter - Dryvax
New Black Box warning for cardiac events and other safety information.
November 5, 2004 Approval Letter - Dryvax
Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults.
June 26, 2003 Approval Letter - Dryvax
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.
October 25, 2002 Approval Letter - Dryvax
Active immunization against smallpox disease.