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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Internal Review Memorandum - VARZIG, December 11, 2012

Our Reference: BL 125430/0

Cangene Corporation
Attention: Mr. Terry Kraynyk
December 11, 2012
Sent by email

Dear Mr. Kraynyk:

We are reviewing your June 29, 2012 biologics license application (BLA) for Varicella Zoster Immune Globulin (Human). We request that you make the following postmarketing commitment:

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The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.

Please submit your response to this information request as an amendment to this file by December 13, 2012 referencing the date of this request. 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.

The action due date for this file is December 29, 2012.

If you have any questions, please contact me at (301) 827-6174.

Sincerely,

Nannette Cagungun
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB