Vaccines, Blood & Biologics
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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)
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