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:

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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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