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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Labeling Comments - VARIZIG, November 29, 2012

From: Cagungun, Nannette
Sent: Thursday, November 29, 2012 4:42 PM
To: Terry Kraynyk
Subject: Labeling Comments- Varizig

Attachments: 125430 proposed-labeling-text rev FDA 11_29_12.pdf


Our Reference: STN 125430/0

Cangene Corporation
Attention: Mr. Terry Kraynyk
November 29, 2012
Sent by email

Dear Mr. Kraynyk:

Attached is a PDF file that has the source document (WORD) as an attachment that contains FDA revisions to the proposed labeling. Please ensure that the updated references, table of contents, grammar, spelling, etc. are correct.

We also have the following comments for the carton and the container:

CONTAINER LABEL
Please add the following items to each container (vial) label:

  • Lot number
  • Expiration date

PACKAGE LABEL
Please add the following items to each package label:

  • Lot number
  • Expiration date
  • Barcode

DILUENT
Please add the following items to each diluent label:

  • Lot number
  • Expiration date
  • NDC
  • Barcode

Please submit your response to this information request as an amendment to this file by December 5, 2012 referencing the date of this request. Please include both a red-line strike out and clean copy of the revised package insert in WORD format. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.

Sincerely,
Nannette Cagungun, MS, PD, RAC
Regulatory Project Manager
OBRR/CBER/FDA, HFM-380
1401 Rockville Pike Rockville, MD 20852-1448
Tel: (301) 827 6174
Fax: (301) 827 2857
Email: nannette.cagungun@fda.hhs.gov


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