Product Approval Information - Licensing Action
March 26, 2008
Our STN: BL 103475/5195
GlaxoSmithKline Biologicals
Attention: Wendy Valinski
2301 Renaissance Boulevard
King of Prussia, PA
Dear Ms. Wendy Valinski:
We have approved your request to supplement your biologics license application for Hepatitis A Vaccine Inactivated coadministration of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar®) with Hepatitis A Vaccine Inactivated (Havrix®) for children in the second year of life.
This fulfills your commitment(s) to assess the safety and immunogenicity of concurrent administration of HAVRIX® (720 EL.U/0.5 mL dose) with PREVNAR® in healthy children 12 to 15 months of age as stated in commitment number 2 of the October 17, 2005, approval letter (STN: 103475/5090).
Since this supplement application does not contain a new active ingredient, new dosage form, new indication, new route of administration, nor new dosing regimen, there is no requirement for an assessment of the safety and effectiveness in pediatric patients per the Pediatric Research Equity Act.
We acknowledge your written commitment as described in your e-mail of February 28, 2008, to provide clarification in the Havrix® annual report of the terms cut-off value and LOQ in the corresponding validation report (SP22F1DPCV01) and method SOP (RD-CIB-035).
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide this labeling as a PDF-format electronic copy.
In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
/Loris D. McVittie, Ph.D./
Loris D. McVittie, Ph.D.
Acting Director
Viral Vaccine Branch
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling