Product Approval Information - Licensing Action

October 2, 2007

Submission Tracking Number (STN): BLS 101106/5089

Jack D. Love, Ph.D.
Wyeth Pharmaceuticals, Inc.
One Blue Hill Plaza, BH 21-125
Pearl River, NY 10965-8668

Dear Dr. Love:

We have received your July 5, 2007, Labeling Supplement to your Biologics License Application for Smallpox Vaccine, Dryvax®, to include additional language regarding skin lesions at the smallpox vaccination site.

This acknowledgment recognizes that your submission is in the form of a "Supplement-Changes Being Effected" as described under 21 CFR 601.12(f)(2). Continued use of the change is subject to final approval of this Supplement.

This Supplement has been reviewed under STN 101106/5089 and is approved effective this date.

This information will be included in your License Application File.

Sincerely yours,

--- signature ---

Janice M. Soreth, M.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research