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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-1448
November 5, 2004
Our STN: BL 101106 / 5057
Dennis Foley
Wyeth Pharmaceuticals, Inc.
401 N. Middletown Road
Pearl River, NY 10965
Dear Dr. Foley:
The Labeling Supplement to your Biologics License Application for Smallpox Vaccine, Dried, Calf Lymph Type, Dryvax, to include a Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults, has been approved. Additional warnings and indications have also been added.
This acknowledgement recognizes that your submission is in the form of a "Supplement-Changes Being Effected" as described under 21 CFR 601.12(f)(2).
This Supplement has been reviewed under STN 101106/5057 and is approved effective this date.
This information will be included in your License Application File.
Sincerely,
--- signature ---
Karen Goldenthal, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
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