October 1, 2002 Approval Letter - Prevnar
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
October 1, 2002
Submission Tracking Number: 103905/1003
Jack D. Love, Ph.D.
Lederle Laboratories Division
American Cyanamid Company
401 N. Middletown Road
Pearl River, NY 14586
Dear Dr. Love:
The Supplement to your License Application for Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), "Prevnar," to include the use of this product for active immunization of infants and toddlers against otitis media caused by vaccine serotypes as an additional indication, has been approved.
This information will be included in your License Application File.
It is required that adverse experience reports be submitted in accordance with the adverse events reporting requirements for licensed biological products (21 CFR 600.80) and that distribution reports be submitted as described (21 CFR 600.81). All adverse experience reports should be prominently identified according to 21 CFR 600.80 and be submitted to the Center for Biologics Evaluation and Research, HFM-210, Food and Drug Administration 1401 Rockville Pike, MD 20852-1448.
It is required that reports of errors and accidents in manufacture be submitted in accordance with the error and accident reporting requirements for licensed biological products (21 CFR 600.14). All error and accident reports should be identified promptly according to 21 CFR 600.14 and submitted to the Director, Office of Compliance, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.
Please submit four copies of final printed labeling at the time of use and include the label transmittal form FDA 2567 with completed implementation information. In addition, please submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2567 or Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Staff, HFM-202, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by an FDA Form 2567 or Form 2253.
All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim of superiority over other products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.
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Karen L. Goldenthal, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research