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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Letter - VARIZIG, November 8, 2012

Our Reference: STN 125430/0

Cangene Corporation
Attention: Mr. Terry Kraynyk
November 8, 2012
Sent by email

Dear Mr. Kryanyk:

We are reviewing your biologics license application for Varicella Zoster Immune Globulin (Human) submitted on June 29, 2012 for post exposure prophylaxis of varicella in high-risk individuals. We have the following request for information:

1. Study VZ-006 did not show a statistically significant difference in performance of VariZIG and VZIG. Based on this result you wrote:

“In summary, VariZIG was shown to be well-tolerated and with an efficacy profile comparable to that of licensed VZIG, in preventing or modifying the course of varicella infection in pregnant women without immunity to VZV.” (2.7.6 Synopses of Individual Studies, page 9)

Please provide a precise statistical hypothesis tested in this study that can explain the term “comparable.”

Please submit your response to this information request as an amendment to this file by November 15, 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.


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


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


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