
Record of Telephone Conversation, Residual Kanamycin, January 19, 2015 - 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: 19-Jan-2015 01:00 AM     Initiated by FDA? Yes

Telephone Number: 866-755-6294

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
 Tcon to discuss residual Kanamycin present in the DP

FDA Participants: KIRK PRUTZMAN, JOHN CIPOLLO, TINA ROECKLEIN, MARGARET BASH

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

CBER and Novartis met to discuss residual Kanamycin in the final drug product. CBER asked Novartis if the proposed statement in the Package Insert and Carton Labels (Kanamycin is present at less than 0.01 mcg/dose) is correct. Novartis indicated that it was an accurate statement. CBER indicated that they were not able to find the supportive data in the BLA and suggested that Novartis provide data to support the statement. CBER indicated that Novartis could show that residual Kanamycin is present at less than 0.01 mcg/dose by either providing testing results on the DP or by calculating the residual Kanamycin using the manufacturing information. Novartis indicated that they will be able to provide a calculation of the residual Kanamycin as they have not tested the final DP for residual Kanamycin. CBER asked Novartis to submit data (including the calculations) to support this claim. Novartis agreed.

Call Ended.
