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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Filing New Dietary Ingredient Letter - Q-Pan

Our STN:  BL 125419/0

GlaxoSmithKline Biologicals
Attention:  Ms. Katalin G. Abraham
2301 Renaissance Boulevard
P.O. Box 61540
King or Prussia, PA 19406-2772

Dear Ms. Abraham:

This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated February 22, 2012, for Influenza A (H5N1) Virus Monovalent Vaccine to determine its acceptability for filing.  Under 21 CFR 601.2(a) we have filed your application today.  The review goal date is December 22, 2012.  This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted. 

We will contact you regarding your proposed labeling no later than November 22, 2012.  If post marketing study commitments (506B) are required, we will contact you no later than
November 22, 2012.

At this time, we have not identified any potential review issues.  Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application.  Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.

If you have any questions, please contact the Regulatory Project Manager, Jeremy Wally, at (301) 796-2640.

Sincerely yours,

Wellington Sun, M.D.
Division Director
Division of Vaccine and
Related Product Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research