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Vaccines, Blood & Biologics
Dryvax
Proper Name: Smallpox Vaccine, Dried, Calf Lymph Type
Tradename: Dryvax
Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003
Indication:
- Active immunization against smallpox disease
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Supporting Documents
- Dryvax - October 2, 2007 Approval Letter
Labeling Supplement: Include additional language regarding skin lesions at the smallpox vaccination site. - Dryvax - October 11, 2005 Approval Letter
Labeling Supplement: New Black Box warning for cardiac events and other safety information. - Dryvax - November 5, 2004 Approval Letter
Labeling Supplement: Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults. - Dryvax - June 26, 2003 Approval Letter
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. - Dryvax - October 25, 2002 Approval Letter
Indication: Active immunization against smallpox disease. - Women with Smallpox Vaccine Exposure During Pregnancy Reported to the National Smallpox Vaccine in Pregnancy Registry
MMWR - May 2, 2003 - Dryvax (Smallpox Vaccine) Questions and Answers
- Questions and Answers on FDA Guidance Entitled "Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients"
1/15/2003 - Smallpox Vaccine
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