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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resubmission Acknowledgment Letter - EVARREST

Our STN: BL 125392/0

Ethicon Inc
Attention: Ms. Raina Dauria
G-106-10, P.O. Box 151, Route 22 West
Somerville, NJ 08876-0151

Dear Ms. Dauria

We have received your March 29, 2012 resubmission to your biologics license application for Fibrin Pad, on March 30, 2012. This resubmission contains information in response to our September 19, 2011 complete response letter.

We consider this a complete, class 2 response to our action letter. Therefore, the user fee goal date is September 29, 2012.

If you have any questions, please contact the Regulatory Project Manager, Tracy Tilghman, at (301) 827-9427.

Sincerely yours,

 

Iliana Valencia
Chief, Regulatory Project Management Branch
Office of Blood Research and Review
Center for Biologics
Evaluation and Research