Labeling Review Memo, October 31, 2012 - Flucelvax
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
To: The File of STN 125408/0
Date: October 31, 2012
STN #: 125408/0
Supplement Type: Original Submission
Sponsor: Novartis Vaccines and Diagnostics, Inc.
Product: Flucelvax, Influenza Virus Vaccine
From: Timothy A. Fritz, Ph.D.
This original submission included carton and container labels and a proposed package insert (PI) incorporating safety and efficacy data collected from clinical studies conducted in adult and elderly populations. Revisions to the proposed labels and PI were communicated to the sponsor as indicated below. The sponsor’s responses to CBER’s suggested revisions were submitted in Amendments 20, 25, 32, and 42. The principal reviewers of the package insert were the Clinical Reviewer and supervisors and the Advertising and Promotional Labeling Branch with additional advice from the OVRR IOD.
The following is a list of CBER labeling activities and CSL labeling amendments submitted to this supplement:
Review Team Labeling Meeting Dates:
May 17, 2012
August 8, 2012
August 23, 2012
September 11, 2012
CBER Labeling Information Request Dates:
June 28, 2012
August 2, 2012
August 10, 2012
August 30, 2012
September 14, 2012
September 20, 2012
September 21, 2012
October 12, 2012
October 19, 2012
Novartis amendments containing revisions to the Package Insert and/or carton and container labels:
Sections 4 (Contraindications) and 11 (Description) of the PI were revised to remove claims that the vaccine contained no egg proteins since the seed virus used for manufacture was passaged in eggs and the final product was not tested to ensure the absence of egg proteins. Section 11 of the PI was revised to include the quantities of the residual components listed. CBER also requested that the immunogenicity results in Tables 5 and 6 for persons 18 through 49 years of age and persons 50 through 64 years of age be presented in separate columns. Additional revisions were made, where appropriate, to harmonize the Flucelvax PI and carton and container labels with other influenza vaccine labeling.
The final version of the PI was submitted on October 23, 2012 (Amendment 42) and reviewed by review team members. Additional minor changes were recommended by the review team but Novartis had already begun printing the PI due to its printing schedule. In an October 26, 2012 telecon, CBER requested that Novartis commit to making the recommended changes to the PI for the 2013-2014 influenza season. The version of the PI submitted in Amendment 42 is considered the Final Draft Label for approval.