Record of Telephone Conversation - VARIZIG, December 5, 2012

RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125430/0 Office: OBRR

Product:
Varicella Zoster Immune Globulin (Human)

Applicant:
Cangene Corporation

Telecon Date/Time: 05-Dec-2012 04:00 PM Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s):
1. Information Request

Author: NANNETTE CAGUNGUN

Telecon Summary:
To discuss facility issues

FDA Participants: Nannette Cagungun, Destry Sillivan, Chiang Syin, Michael Vardon, Maria Luisa Virata, Pei Zhang

Non-FDA Participants: 
Terry Kraynyk    Manager Regulatory Affairs
Shelley Toth       Senior Associate Regulatory Affairs
Lori Soluk           Manager of Validation

Agenda: FDA would like to discuss with Cangene deficiencies noted in the -b(4)---------- qualification associated with use of the ---b(4)----------------------------------------------------. FDA believes this issue may be resolved by an agreed upon Post Marketing Commitment (PMC). FDA also discussed --------b(4)--------------------- deficiencies, which it believes can also be resolved with an agreed upon PMC. 

Telecon Body:
After introductions, FDA asked if the –b(4)-------------- will be the final container for Varzig. Cangene said the –b(4)---- will be the primary vial. The FDA stated that the –b(4)--------------------------------------- is similar but not exactly the same as the ---b(4)------------------------ Further, the Varzig BLA does not contain data showing that Cangene had performed extended –b(4)----------- validation studies in support of use of the –b(4)-----. FDA stated that this issue could be addressed by providing supportive data from another, very similar Cangene licensed product, such as WinRho, due to limited production of Varzig.


With regard to the ----b(4)--------------------------------------- FDA noted that Cangene had stated that vials with defects of known sizes are not usually incorporated in –b(4)-- studies. FDA stated that containers with known defects approaching a –b(4)--------- (in the absence of a determination of the limit of sensitivity, limit of detection, or both) should be included as –b(4)-------------- for the test. Therefore, FDA will require that Cangene commit to performing a new –b(4)-- study that utilizes appropriate ---b(4)--------- 
Cangene said they will perform validation studies using the –b(4)------------------- in the --b(4)--------- as an agreed upon PMC. 
FDA asked if Cangene has submitted a similar –b(4)---- to their other licensed products. FDA asked Cangene to let the Agency know about any other supplements under review that involve –b(4)--------


Cangene responded that only Varizig is undergoing –b(4)------- The previous WinRho product was supplied in a lyophilized powder. Cangene only manufactures a liquid formulation of WinRho today for the US market. However, WinRho is manufactured as a lyophilized product for market in other countries, and Cangene could provide the required -b(4)---------- study data from manufacture of this product.


FDA asked Cangene to address changes related to a –b(4)------- in all of their licensed products. Cangene indicated that they will need to look at the production schedule for the next lyophilization run availability.


FDA reiterated its concern regarding Cangene’s deficiency in reporting the –b(4)------- when Cangene mentioned that they did not consider this a significant change.


Cangene will draft language for the PMC and submit it for FDA comments by Monday, December 10, 2012.
Action Items:
1.----b(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2.FDA will reiterate the importance of reporting the change in the –b(4)------------ to Cangene. It is the ---b(4)-------------------------------------. There is really no more measure to correct the problem if the product quality or sterility is compromised in the b(4) whether it's during ---b(4)------------------------ (2nd PMC).
