January 31, 2002 Approval Letter
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
January 31, 2002
Our STN: BL 103821/5020
Lallan Giri, Ph.D.
3500 N. Martin Luther King Jr. Blvd.
Lansing, MI 48906
Dear Dr. Giri:
Your request to supplement your biologics license application to include Hollister-Stier Laboratories LLC, Spokane, Washington, as a contract manufacturer for the filling of Anthrax Vaccine Adsorbed (AVA) has been approved.
Under this approval, lots of AVA filled at Hollister-Stier Laboratories LLC shall have an expiration dating period of 18 months from the date of manufacture when stored at 2-8 °C. Any requests to extend the dating period beyond 18 months will require the submission of supporting data as a supplement to your biologics license application for review and approval.
We acknowledge your written commitments, as stated in your letter of January 17, 2002, to provide the following additional information post-approval:
- Real time stability data on final containers for the consistency lots, FAV063, FAV064 and FAV065, will be accumulated at the following intervals: 6, 9, 12, and 18 months, and these stability data will be provided to CBER as they become available.
- BioPort has committed to place a minimum of two filled lots of AVA on stability each year.
- To perform a suitable extraction study for the West Stoppers using the diluent of the Anthrax Vaccine Adsorbed. The study will be completed by July 2002 and the results submitted to CBER in the next annual report.
The information contained in the above-referenced supplement will be included in your biologics license application file.
--- signature ---
Steven A. Masiello
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research