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 Confirmation Letter - Anascorp


Our STN: BL 125335/0
Rare Disease Therapeutics, Inc.
Attention: Mr. Milton H Ellis
2550 Meridian Boulevard, Suite 150
Franklin, TN 37067
Dear Mr. Ellis:
We have received your January 31, 2011 resubmission to your biologics license application for Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine) on February 1, 2011.
The resubmission contains your responses to our July 23, 2009 complete response letter. 
We consider this a complete, Class 2 response to our action letter. Therefore, the user fee goal date is August 3, 2011.
If you have any questions, please contact the Regulatory Project Manager, Debra Cordaro, at 301-827-6157.
Sincerely yours,
Alan E. Williams, Ph.D.
Associate Director for Regulatory Affairs
Acting Chief, Regulatory Project
 Management Branch
Office of Blood Research and Review
Center for Biologics

Page Last Updated: 03/25/2015
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