Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

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


Page Last Updated: 01/04/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English