Product Approval Information - Licensing Action Proper name: Smallpox Vaccine, Dried, Calf Lymph Type Tradename: Dryvax Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003 Package Insert Revision: Include 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 Approval Date: 6/26/2003 Type of submission: Biologics license application supplement Approval Letter - (Text) Label - (PDF) 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 Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products... Questions and Answers on FDA Guidance Talk Paper Smallpox Information Page

Updated October 30, 2003

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