
OVRR Lot Clearance Request Email, May 09, 2012 - MenHibrix

 
 
From: Staten, David
Sent: Wednesday, May 09, 2012 2:23 PM
To: CBER Lot Clearance
Cc: Temenak, Joseph; Prutzman, Kirk C
Subject: OVRR Lot Clearance request STN 125363/0

-b(4)- lots were submitted on December 21, 2011 (---b(4)------------------------------). At the time of approval there will not be any launch lots. The sponsor estimates that the launch lots and reagents will available toward the end of July.

Please confirm that there are no lots associated with this Supplement.

STN: 125363/0

Lic. #: 1617

Company/Address :

GlaxoSmithKline Biologicals, S. A. d/b/a GlaxoSmithKline 
Rue de l'Institut 89 
B-1330 Rixensart 
BELGIUM

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Product: meningococcal and Hib TT conjugate vaccine

Subm Type: BLA 

First Action Due Date: June 1, 2012

Short Summary: 
active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y

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David Schwab, MSIS 
LT, USPHS 
Food and Drug Administration 
Office of Vaccines Research and Review 
office (301)-796-1788 
cell ----b(6)--------------------
