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Vaccines

Review of Results Memo, November 11, 2010 - Flublok

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
Rockville, MD 20852-1448

 

Date                November 11, 2010
 
From              Arifa S. Khan, PhD
 
To                  FILE STN 125285-0.35 (dd September 10, 2010) and
                       FILE STN 125285-0.37 (dd October 6, 2010)
 
Subject           Review of updated results of investigations of –b(4)-------
 
Product         Influenza Vaccine, FluBlok, Purified Recombinant Influenza
                       Hemagglutinin (derived from H1, H3, B viral strains)
 
Sponsor         Protein Sciences Corporation
 
Through        Jerry Weir, PhD
                       Hana Golding, PhD
 
cc                   Rakesh Pandey, PhD
                       Tim Fritz, PhD
                       Maryna Eichelberg, PhD                    
 
 
These submissions contains PSC’s update on –b(4)-------------------- assays on FluBlok final container drug products –b(4)---------------------------------- regarding continued investigations in response to FDA’s Comment 2 of the January 11, 2010 Complete Response (CR) letter submitted on June 29, 2010. Detailed background regarding the b(4) results up to these submissions is provided in my review of August 12, 2010 regarding responses to FDA CR letter dd Jan 11, 2010 amendment 0.31 (vol 2, dd June 29, 2010).
 
FDA COMMENT 2) In response to CBER’s November 6, 2009, Information Request (Item #5cii), you indicated in your December 11, 2009, submission that –b(4)----- was detected in the two trivalent vialed batches of FluBlok, drug product lot #50-70710 and lot # 701703F. Please submit these test results once the final report is available from
 
 
 
3 Pages determined to be not releasable: b(4)