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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Letter Regarding Biologics License Application (BLA) for Fibrin Sealant Patch - TachoSil, June 3, 2009

Our STN: BL 125351/0

Nycomed Danmark ApS
Attention: Ms. Camilla Wamberg
Langebjerg 1
DK-4000 Roskilde
Denmark

Dear Ms. Wamberg:

This letter is in regard to your Biologics License Application (BLA) for Fibrin Sealant Patch submitted under section 351 of the Public Health Service Act on June 3, 2009 (receipt date June 5, 2009).

We have completed an initial review of your application dated June 3, 2009, for Fibrin Sealant Patch to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your application today.  The review goal date is April 5, 2010.  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 March 6, 2010.  If  postmarketing study commitments (506B) are required, we will contact you no later than March 6, 2010.

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, Jie He, at (301) 827-9167.

Sincerely yours,

 

Sheryl Kochman
Acting Director
Division of Blood Applications
Office of Blood Research and Review  
Center for Biologics Evaluation and Research