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
Author: DARYLL MILLER
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
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.