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Vaccines, Blood & Biologics

Telecon - August 28, 2009 - Gammaplex


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


Immune Globulin Intravenous (Human)


Bio Product Laboratory          

Telecon Date/Time:  28-AUG-2009 10:30 AM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):



Telecon Summary: Telecon regarding proprietary name, and outstanding issues telecon

FDA Participants:   Michael Kennedy, Dorothy Scott, Hon-Sum Ko, Debbie Cordaro

Non-FDA Participants:   


Dr. Clive Dash – Medical Director

Sam Leach – Clinical Project Leader

Chris Dunkerley – Senior Regulatory Affairs Officer

Tara Dolan – R&D Senior Project Scientist

Arlene Mijalenko – Product Manager







Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

Was BPL was notified during the IND stage that FDA considered the proprietary name (Gammaplex) “Accepted with Concerns”?  BPL stated they were not.  FDA explained, that in the time since BPL’s proprietary name was reviewed, there has been a change in the SOPP. 

When BPL was recently notified that the proprietary name was unacceptable, the decision had not been vetted up through the OBRR management.  FDA commented that there are concerns regarding the “- PLEX” portion of the name because there are other products sounding similar.  At the time this product becomes available, if FDA becomes aware of medical errors due to name confusion, FDA may revisit the issue of the name.

FDA inquired about the status of the following issues:

Lot release templates:  BPL commented they have completed the revisions to the templates. The -(b)(4)- lot serves as the third conformance lot; however, the diphtheria testing is not complete on this -(b)(4)- lot.  BPL stated the standard must be re-standardized and the diphtheria testing (at -(b)(4)-) will need to be repeated.  The planned release of Lot -(b)(4)-, will be distributed, but not before November and it will be shipped for US distribution.

Stopper in PI has been revised.  Firm noted that they reevaluated the stopper and they could not be assured it is latex free.  The change in the package insert did not reflect a  change in the stopper.


Production:  There is another batch for the ITP clinical trial.  A -(b)(4)- batch is expected to be available in October and will be shipped to the US.

Revised label;  Fructose intolerance information should be removed from the Contraindications section and added to the Warnings and Precautions section.  The Contraindication section is for substantiated concerns derived from clinical data with this product.

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