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Vaccines

Record of Telephone Conversation - February 23, 2010 - Prevnar 13

System Info - 120984  SMITH, MICHAEL J  23-Feb-2010 21:25:18  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  23-FEB-2010 09:08 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Labeling via FAX/e-mail

Author:  JULIENNE VAILLANCOURT

Telecon Summary:
Final draft label

FDA Participants:   Julie Vaillancourt, Collen Sweeney and Mike Smith

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

______________________________________________

From:                     Vaillancourt, Julienne 

Sent:                      Tuesday, February 23, 2010 9:08 PM

To:                          'Love Jack'; Devlin Carmel

Cc:                          Smith, Michael (CBER); Sweeney, Colleen

Subject:                Final Approved Draft Labeling

Dear Jack and Carmel,

This is to acknowledge our receipt of revised draft labeling, submitted as an official amendment to the BLA this evening (serial 91, amendment 94).  The draft labeling in this amendment replaces the version of the draft labeling received on February 19, 2010, and includes the changes, requested by CBER during the telecon earlier this evening, and thus, is the final approved draft labeling.

Thank you.

Julie

Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Regulatory Reviewer
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration

Phone:    301-827-5414
Fax:        301-827-3532
E-mail:   julienne.vaillancourt@fda.hhs.gov

 

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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448