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TeleCon, PNR Review, December 15, 2008 - Adenovirus

Submission Type: Original Application   Submission ID:  125296/0    Office: OVRR  

Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant:                                                                         Duramed Research Inc.          

Telecon Date/Time:  15-DEC-2008 12:00 AM     Initiated by FDA?  Yes
Telephone Number:  610-747-2664

Communication Categorie(s):
Information Request


Telecon Summary:
Requested Proprietary Name Review request from Sponsor.

FDA Participants:   Daryll Miller

Non-FDA Participants:    John Pakulski

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

John Pakulski, Director of Regulatory Affairs at Duramed Research was contacted and advised that Duramed needs to submit a new request for Proprietary Name Review (PNR) with new labeling and materials and officially withdraw the trade name submitted in the original BLA.  Duramed was advised that the PNR should be submitted via an official amendment to the BLA and is required in advance of the midcycle date of February 27, 2009.