Record of Telephone Conversation - Cervarix, June 29, 2009 PM

System Info - 97982  SHONE, DEANNA   30-Jun-2009 10:02:22  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  29-JUN-2009 07:08 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Cervarix Proper Name

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No    

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Gemignani, Helen S
Sent: Monday, June 29, 2009 7:08 PM
To: 'Matt.Whitman@gsk.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'nicholas.perombelon@gskbio.com'
Subject: Cervarix Proper Name

CBER has determined that the following proper name be used for CERVARIX:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070