Product Approval Information - Licensing Action

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

October 25, 2002

Our STN: BL 101106/5015

Amy J. Criswell
Wyeth Laboratories, Inc.
P.O. Box 304
Wasp & Biddle Streets
Marietta, PA 17547

Dear Ms. Criswell:

The Supplement to your Biologics License Application for Smallpox Vaccine, Dried, Calf Lymph Type, Dryvax®, to include a new 100-dose kit, has been approved. The kit contains 1 vial of lyophilized vaccine, one pre-filled diluent syringe, one transfer needle, and one box of bifurcated needles. Please note that the ----------------------------------------------------------------- -------------------------------------------------------------------------------------------------. We also note that final labeling for the kit was reviewed and approved under a separate supplement (STN 101106/5009).

The initiation of the dating period is the date of transfer of product from -20°C to 2-8°C. The limit of dating for the lyophilized product is 24 months at 2-8°C. The reconstituted vaccine may be held at 2-8°C for 30 days.

The revised lot release protocol requires ------- testing and ------ testing. This product will be released via CBER lot release procedures provided the lot has been stored continuously at -20°C, test results for the lot are within revised release protocol specification, and the lot has passed all previous release testing, e.g., --------. Lots that do not meet these conditions will require submission and approval of a CMC supplement for release.

This information will be included in your License Application file.

Sincerely yours,
--- signature ---

Jerry P. Weir, Ph.D.
Director
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research