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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Questions on Vial Hanger Email, May 20, 2011 - Kedbumin

From: Allard, Crystal
Sent: Friday, May 20, 2011 3:39 PM
To: ----------(b)(4)------------
Cc: -------------(b)(4)---------------
Subject: RE: Kedrion KEDBUMIN - additional question regarding addition of the vial hanger
HI ---(b)(4)---,

We have discussed this and want to confirm that you do not need to submit the additional of the extensible hanger to the current, original BLA.

However, while discussing this issue, we discovered that two updates need to be made to your outermost container label.

1) The Proper Name must be at least the same size (larger is OK, smaller is not) as the the Trade Name.
2) USP appears directly next to the Trade Name. This is not acceptable, as it appears that the Trade Name is Kedbumin USP. Please move USP away from the Trade Name on the label.

Please submit revised labels as an amendment to 125384/0 by the end of the day, Monday May 23rd, if possible.  I'm sorry for the extremely tight deadline.

Best,

Crystal


From: -------------------------(b)(4)--------------------------------------
Sent: Wednesday, May 04, 2011 8:15 AM
To: Allard, Crystal
Cc: -------------(b)(4)---------------
Subject: Kedrion KEDBUMIN - additional question regarding addition of the vial hanger
Hello Crystal,

Kedrion has provided a pdf of the proposed container label with the extensible hanger.  I have attached it to this email.  The text on the label has not changed from what was previously submitted.

Kedrion would like to launch this product in the US using the attached container label with the extensible hanger. 

Can you confirm that upon approval of the KEDBUMIN BLA, Kedrion will be able to use this label on product sold in the US and they can report this change in the annual report?  Or, since this label is ready now, could we submit it to the BLA without affecting the PDUFA date?

Sincerely,

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