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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request -VARIZIG, October 9, 2012

From:                     Cagungun, Nannette
Sent:                      Tuesday, October 09, 2012 5:10 PM
To:                         'Terry Kraynyk'
Subject:                 VariZiG -information request October 9, 2012

 
Our Reference: STN 125430/0
 
Cangene Corporation
Attention: Mr. Terry Kraynyk
October 9, 2012

Dear Mr. Kraynyk:
 
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 additional request for information:
            DMPQ:
            -----b(4)------------------------------------------------ -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
Please submit your response to this information request as an amendment to this file by October 18, 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
Email: nannette.cagungun@fda.hhs.gov
 
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