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Vaccines

Email - Proprietary Name Withdrawal, February 17, 2009 - Adenovirus

From:                     Hithe, Darlene
Sent:                      Tuesday, February 17, 2009 5:40 PM
To:                         'Pakulski, John'
Cc:                         Miller, Daryll L; Gemignani, Helen S
Subject:                 Adenovirus BLA 125296 - Proprietary Name Withdrawal
Hello John,

Today, we had a discussion with the labeling staff regarding the proprietary name change.  Duramed needs to submit a withdrawal of the --(b)(4)-- name along with corrected cartons, containers, and labeling package inserts so that the labeling review can proceed without a proprietary name.  Duramed may formally submit a request for a new proprietary name later as long as it is received at least 90 days prior to the action due date of July 31, 2009.  Additionally, once the withdrawal has been submitted, all further correspondence should no longer contain the --(b)(4)-- name.  Although it would have been more efficient to submit the withdrawal and a new name request as one amendment, it is necessary to have the withdrawal request immediately in the interest of not delaying the approval.

If you have any questions, feel free to contact me via email or phone.

Best Regards,
Darlene Hithe

Darlene Hithe
Regulatory Project Manager
FDA/CBER/OVRR/DVRPA
1401 Rockville Pike, HFM-478
Rockville, MD 20852-1448
Tel.:  301-827-3070
Fax:  301-827-3532
darlene.hithe@fda.hhs.gov
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