• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Information Request -VARIZIG - November 2, 2012

From: Cagungun, Nannette
Sent: Friday, November 02, 2012 7:33 PM
To: Terry Kraynyk
Subject: Information Request: Varizig
Importance: High
Attachments: 125430.0 IR 11_02_12.pdf

Our Reference: STN 125430/0

Cangene Corporation
Attention: Mr. Terry Kraynyk
November 2, 2012
Sent by email

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 request for information:
1---b(4)---------------------------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2. –b(4)---
----b(4)----- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Please submit your response to this information request as an amendment to this file by November 9, 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.

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

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender by e-mail or phone.