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Vaccines

Record of Telephone Conversation - Cervarix, July 10, 2009

System Info - 99742  SHONE, DEANNA   16-Jul-2009 15:58:10  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:  10-JUL-2009 05:00 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

Proprietary Name Acceptable

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No  

Related STNs:  None

Related PMCs:  None

Telecon Body:

FDA -- For Official Use Only

Record of Telecon Page 1

Record of Telephone Conversation

STN Number: 125259/0

Manufacturer: GlaxoSmithKline Biologicals

Product: Human Papillomavirus Vaccine, ASO4 Adjuvant-

Adsorbed

To: File

From: Helen S. Gemignani, Regulatory Project Manager

Subject: Proprietary Name Acceptable

Telecon Date: July 10, 2009 Telecon Time: 5:00pm

Telecon Initiated by: Helen S. Gemignani

Contact Phone: 610 787-3752

Summary of Telecon

I called GSK to inform them that we have considered their proposed

Proprietary Name, Cervarix, in consultation with CBER’s Advertising

and Promotional Labeling Branch, and conclude that under 21 CFR Part

201 the proposed Proprietary Name is acceptable at this time.

End of Teleconference

Action Items

• None

FDA Participants

• Helen S. Gemignani

GSK Participants

• Cynthia D’Ambrosio