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RECORD OF TELEPHONE CONVERSATION

 

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

Product:

Immune Globulin Intravenous (Human), 5% Liquid

Applicant:                                                                       
 

Bio Product Laboratory          

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

Telephone Number:    

Communication Categorie(s):

Advice

Author:  DEBRA CORDARO

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. 
 

   