Information Request - VARIZIG, November 15, 2012

Our Reference: STN 125430/0

Cangene Corporation
Attention: Mr. Terry Kraynyk
November 15, 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. With respect to –b(4)--------------------------------- performed in support of use of the –b(4)--------------------------, please provide the following:

a. Cangene SOP 520026.04 referenced in PV_0212_rep_v1, ---b(4)-------------------------------------------. In addition, clarify if you include, in your –b(4)----------------------------------------------------------------------------------------------------- with known defects. If so, please provide the defect size utilized. If you do include such vials, please specify the defect aperature sized.

b. A more detailed justification as to why you believe data from –b(4)-- studies performed in support of a given vial may be extrapolated to another similar vial.

2. Please clarify if the –b(4)-------------------- 6 mL vial was qualified in the lyophilizer using VariZIG or WinRho, as referenced in process validation report PV_0143.

3. Please confirm if the WinRho lyophilization cycle referenced in V_0143 is –b(4)-- to the VariZIG lyophilization cycle. Clarify if a VariZIG lyophilization process qualification report can be provided. In addition, please provide the VariZIG lyophilization cycle printouts for conformance lots –b(4)----------------- and the applicable WinRho cycle referenced in PV_0143 if the lyophilization cycles are considered –b(4)----- Include the lyophilizer temperature and pressure graphs that confirm adequate lyophilization performance for each critical step.

Please submit your response to this information request as an amendment to this file by November 27, 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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