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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Draft Container and Package Labeling Review


Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research


Date:October 15, 2007
From:Maryann R. Gallagher, Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB) (HFM-602)
Division of Case Management
Through:Ele Ibarra-Pratt, Branch Chief, APLB (HFM-602
To:Karen Farizo, Primary Reviewer, CTB/DVRPA/OVRR, (HFM-475)
Joseph Temenak, RPM, BVB/DVRPA/OVRR, (HFM-481)
Martha Monser, Co-RPM, BVB/ DVRPA/OVRR, (HFM-481)
Subject:Review of GSK's draft container and package labeling for KinrixTM Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Combined
BLA 125260

APLB reviewed the proposed Kinrix container and package labeling in the EDR received in CBER on April 9, 2007. The first action due date is February 7, 2008. APLB has the following comments:

We recommend including the "Rx only" statement to comply with 21 CFR 610.60(a)(6).

We recommend revising the statement "Preservative Free," on the front panel to "No Preservative," to comply with 21 CFR 610.61(e), "if no preservative is used and the absence of a preservative is a safety factor, the words "no preservative," shall appear on the label affixed to each package."

If you have any questions regarding our comments please contact Maryann Gallagher @ 301-827-6330.

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