
Proprietary Name Review Acceptance Email, November 7, 2014 - BEXSERO

 

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR 

Product:
 Meningococcal Group B Vaccine 

Applicant:
 Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 07-Nov-2014 02:52 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s):
 1. Other - 

Author: KIRK PRUTZMAN

Telecon Summary: 
Proprietary Name Review Acceptance - BEXSERO

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Friday, November 07, 2014 2:52 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Proprietary Name Review - BEXSERO

Dr. Stoehr, 

On July 22, 2014, we sent you a Proprietary Name Acceptance letter under IND (b)(4), indicating that your proposed proprietary name, BEXSERO, is acceptable. In this letter we asked you to request another proprietary name review for BEXSERO for further evaluation when submitting your biologics license application (BLA). We have reviewed your proposed proprietary name of BEXSERO submitted to your BLA (STN 125546) and conclude that your proposed proprietary name, BEXSERO, is acceptable at this time.

If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik, or Ed Wolfgang at (301) 796-2640.

Regards,

Kirk Prutzman, PhD
 Primary Reviewer/Regulatory Project Manager 
 CBER/OVRR/DVRPA/CMC3 
 Food and Drug Administration
 10903 New Hampshire Avenue
 Building 71 and Room 3041
 Silver Spring, MD 20993-0002
 Phone: (301) 796-2640
 Fax: (301) 595-1244 
