September 4, 2002 Approval Letter - Fluzone
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
September 4, 2002
Submission Tracking Number (STN): BL 103914/5030
Luc Kuykens, M.D.
Aventis Pasteur Inc.
Swiftwater, PA 18370-0187
Dear Dr. Kuykens:
The Supplement to your Biologics License Application (BLA) for Influenza Virus Vaccine, Fluzone®, to include preservative free formulation in a single dose presentation in 0.25 ml syringes for pediatric use and 0.5 ml syringes for adults and children, has been approved.
We acknowledge the following post marketing commitments (PMC) regarding the Influenza Virus Vaccine (Fluzone®), from the July 31, 2002, amendment to your BLA supplement.
- To provide real time stability data on three consecutive final container lots for both 0.25 mL (Lot #s [------------------------] and 0.5 mL syringes (Lot #s [------------------------] at 3, 6, 9, 12 and 18-month intervals. Data for 3 and 6-month intervals have already been provided. Data for remaining time points will be submitted to the Center for Biologics Evaluation and Research (CBER) as they become available following Aventis Pasteur Inc.'s internal Quality Assurance verification.
- To add the post-approval lots to the stability program according to the normal practice at Aventis Pasteur, Inc.
- To promptly notify CBER if any stability data fall outside of the expectations of the stability protocols.
This information will be included in your Biologics License Application file. It is recommended that a copy of this letter be available for review at the time of FDA inspections.
--- signature ---
Jerry P. Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research