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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-1448
October 11, 2005
Our STN: BL 101106/5067
Jack D. Love, Ph.D.
Wyeth Pharmaceuticals, Inc.
One Blue Hill Plaza, BH 21-125
Pearl River, NY 10965-8668
Dear Dr. Love:
The Labeling Supplement to your Biologics License Application for Smallpox Vaccine, Dried, Calf Lymph Type, Dryvax, to include a new Black Box warning for cardiac events and other safety information, has been approved.
This information will be included in your License Application file.
Sincerely yours,
--- signature ---
Karen L. Goldenthal, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachments: Package Insert/Forms 2567.
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