
Communication of Established Name Email, October 31, 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: 31-Oct-2014 03:09 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Other - 

Author: KIRK PRUTZMAN

Telecon Summary: 
Communication of Established Name - “Meningococcal Group B Vaccine”

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, October 31, 2014 3:09 PM
 To: 'Stoehr, Patricia'
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: RE: BLA 125546 Established name for Bexsero 

Dr. Stoehr,

We have discussed your proposal to change the established name and have determined that the established name will remain “Meningococcal Group B Vaccine”. This established name is consistent with CBER’s naming scheme, conveys the identity of the product, and is clear. While we acknowledge your argument to have a distinguishing established name, CBER has concluded that the proprietary name serves this purpose. 

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

From: Stoehr, Patricia [mailto:patricia.stoehr@novartis.com] 
 Sent: Tuesday, October 21, 2014 6:03 PM
 To: Prutzman, Kirk C
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: RE: BLA 125546 Established name for Bexsero 

Dear Dr. Prutzman,

In order to prepare the drafts of the promotional material for submission and review to CBER we are still waiting for your feedback on our proposal for the established name of the Bexsero vaccine. We would greatly appreciate CBER’s response on this proposal.

Best regards,
 Patricia

*********************************
 Patricia Stoehr
 Director Regulatory Affairs 
 Novartis Vaccines & Diagnostics
 350 Massachusetts Avenue
 Cambridge, MA 02139 
 USA
 Phone: +1 617 871-8060
 Fax: +1 617 871-4711
 Email : patricia.stoehr@novartis.com
 ***************************************

From: Stoehr, Patricia 
 Sent: Friday, October 03, 2014 3:08 PM
 To: 'Kirk.Prutzman@fda.hhs.gov'
 Cc: 'Edward.Wolfgang@fda.hhs.gov'; 'Ramachandra.Naik@fda.hhs.gov'
 Subject: BLA 125546 Established name for Bexsero 

Dear Dr. Prutzman,

In regard to the established name for Bexsero “Meningococcal Group B Vaccine” mentioned in your email below Novartis has the following concerns. 

The Meningococcal Group B vaccines currently under CBER review are not interchangeable. Having the same name for these products introduces the potential for medical errors. Physicians relying on the established name of the vaccine might use these products interchangeably for first and second doses. Novartis believes it will be important to have a distinguishing established name to ensure differentiation of the two vaccines, and is proposing the following for Bexsero:

4-component Meningococcal Group B Vaccine, recombinant, adsorbed

Or alternatively:

Meningococcal Group B Vaccine (4 component, recombinant, adsorbed)

Novartis welcomes the opportunity to further discuss these established name proposals.

Best regards,
 Patricia

*********************************
 Patricia Stoehr
 Director Regulatory Affairs 
 Novartis Vaccines & Diagnostics
 350 Massachusetts Avenue
 Cambridge, MA 02139 
 USA
 Phone: +1 617 871-8060
 Fax: +1 617 871-4711
 Email : patricia.stoehr@novartis.com
