

Letter to Dendreon Corporation - Provenge, January 11, 2007


 
DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration
 1401 Rockville Pike
 Rockville, MD  20852-1448

Our STN:  BL 125197/0                                                         
January 11, 2007

Dendreon Corporation
 Attention:  Elizabeth C. Smith
 Vice President of Regulatory Affairs
 3005 First Avenue
 Seattle, WA 98121

Dear Ms. Smith:

This letter is in regard to your biologics license application (BLA) submitted 
under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated November 9, 2006 
for Sipuleucel-T to determine its acceptability for filing.  Under 21 CFR 
601.2(a), we have filed your application today.  The review goal date is May 15, 
2007.  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. 

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, Lori 
Tull, at (301) 827-5102.

Sincerely yours,

 

Raj K. Puri, M.D., Ph.D.
 Director
 Division of Cellular and Gene Therapies
 Office of Cellular, Tissue, and Gene Therapies
 Center for Biologics Evaluation and Research
 

   