FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Product Approval Information - Licensing Action

horizontal rule

Proper name: Smallpox Vaccine, Dried, Calf Lymph Type
Tradename: Dryvax
Manufacturer: Wyeth Pharmaceuticals, Inc, Pearl River, NY, License #0003
Package Insert Revision: Include a Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults
Approval Date: 11/5/2004
Type of submission: Biologics license application supplement

horizontal rule

Approval Letter - (Text)

Label - (PDF)

 

Updated November 5, 2004
 
horizontal rule

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA / Center for Biologics Evaluation and Research