Reducing Respone Time Letter - Evarrest

Our STN: BL 125392/0

 

Ethicon Inc

Attention: Ms. Jessica Chung

G-106-10, P.O. Box 151

Route 22 West

Somerville, NJ  08876-0151

 

Dear Ms. Chung:

 

 

We have received your October 5, 2012 resubmission to your biologics license application for Fibrin Sealant Patch on October 9, 2012.

 

The resubmission contains a revised draft Prescribing Information and Package Label that you submitted in response to our September 28, 2012 complete response letter. 

 

We consider this a complete, class 1 response to our action letter. Therefore, the user fee goal date is December 9, 2012.

 

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

 

Sincerely yours,

 

 /s/

 

Iliana Valencia, M.S.

Chief, Regulatory Project

Management Branch

Division of Blood Applications

Office of Blood Research and Review

Center for Biologics

 Evaluation and Research