Record of Telephone Conversation, PNR Acceptance, September 3, 2014 - TRUMENBA

(System Info - 285317 SMITH MICHAEL 09/04/2014 09:33:31 SMITHM)

RECORD OF TELEPHONE CONVERSATION 

Submission Type: BLA Submission ID: 125549/0 Office: OVRR

Product:
 Meningococcal Group B Vaccine

Applicant: 
Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 03-Sep-2014 05:39 PM     Initiated by FDA? Yes 

Telephone Number: 

Communication Categorie(s):
 1. PNR Acceptance 

Author: MICHAEL SMITH

Telecon Summary: 
PNR acceptable

FDA Participants: Mike Smith, Drusilla Burns, Ted Garnett and Ram Naik

Non-FDA Participants: Carmel Devlin

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 

See e-mail below:

From: Smith, Michael (CBER) [mailto:Michael.Smith2@fda.hhs.gov]
 Sent: Wednesday, September 3, 2014 5:39 PM
 To: Devlin, Carmel
 Cc: Burns, Drusilla L.; Garnett, Theodore; Naik, Ramachandra
 Subject: STN 125549.0: Proprietary Name Review 

Carmel,

We have reviewed your proposed proprietary name of Trumenba and we have the below guidance.

In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB), we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, Trumenba, is acceptable at this time.

Regards,

Mike

- Please confirm receipt of this guidance.

Mike Smith, Ph.D.
 CDR, U.S. Public Health Service
 Regulatory Project Manager 
 U.S. Food and Drug Administration
 Center for Biologics Evaluation and Research
 Office of Vaccines Research and Review
 Division of Vaccines and Related Products Applications 

Phone: 301-796-2640
 Fax: 301-595-1124
 E-mail: michael.smith2@fda.hhs.gov 

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