Record of Telephone Conversation - October 15, 2009-2 - Prevnar 13

System Info - 113346  SHONE, DEANNA   09-Dec-2009 16:41:19  SHONEDE

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:  15-OCT-2009 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  TINA SUE ROECKLEIN

Telecon Summary:
Retention of Sugp ketone

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

RECORD OF TELEPHONE CONVERSATION

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

Manufacturer:   Wyeth Pharmaceuticals Inc.

Telecon Date/Time:  15-OCT-2009        Initiated by FDA?  Yes
Telephone Number: 845-602-1283

Communication Categorie(s): Information Request

Author:  Tina Roecklein

Telecon Summary:

---------------(b)(4)---------------

FDA Participants:  
Tina Roecklein

Non-FDA Participants:   
Carmel Devlin

Telecon Body:

CBER requested that Wyeth submit the data for the percentage of (b)(4) on historical (including clinical) and launch commercial lots of serotype 5 drug substance.  The data will be obtained using a characterization -(b)(4)----method.  The data was submitted October 6, 2009.  The batch analysis data included-(b)(4)-lots. 

CBER contacted Wyeth on October 15, 2009 to confirm that the total amount of lots available was (b)(4).  Wyeth contacted CBER on October 16, 2009 to confirm that only(b)(4) lots have been manufactured and that all the data was submitted in the amendment.