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Vaccines, Blood & Biologics

Telecon Advice - August 25, 2009 - Gammaplex



Submission Type: Original Application   Submission ID:  125329/0    Office: OBRR  


Immune Globulin Intravenous (Human), 5% Liquid


Bio Product Laboratory          

Telecon Date/Time:  25-AUG-2009 12:00 AM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):



Telecon Summary:

 FDA Participants:   Dr. Hon-Sum Ko and Ms. Debbie Cordaro

Non-FDA Participants:    Mr. Howard Smith

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

FDA notes the firm’s current pediatric plan has a date of submission of the data of the pediatric study that is different than the date that is included in the most recent pediatric plan.  The original BLA and the April submission state BPL will submit the data December 2012.  The most recent submission, July 2009, states the data will be submitted April 2013, dependent upon FDA agreement. FDA strongly recommends the firm adhere to the December 2012.   BPL was also asked to provide a date they will submit the protocol, which should be close to the time of the approval, usually one or two months after approval.  Without BPL input, FDA will just assign this date.

FDA informed BPL that there is ongoing internal discussion regarding the proper name. 

FDA’s naming convention has been to use only “Immune Globulin Intravenous (Human).” We are continuing to determine if the addition of 5% Liquid will be acceptable.  The firm was asked to cease any labeling revisions until this is resolved.

Regarding the proprietary name position on the labeling:  FDA clarified that until the proprietary is resolved, the area on the labels/labeling that would be occupied by the proprietary name must be left blank. 

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