
Review Memorandum, July 6, 2009 - Spherusol

 

 

 Date:  06 July 2009 
 To:  
Holly Wieland RN, Regulatory Project Manager, OVRR/DVRPA

Jon Daugherty, PhD, Regulatory Project Manager, OVRR/DVRPA 

 From:  
Ann T. Schwartz, MD

Medical Officer

Clinical Branch (DVRPA) 

Through:  
Douglas Pratt, MD, MPH

Clinical Branch Chief 

 Product:  
Coccidioidin SD (Coccidioides immitis Spherule-Derived Skin Test Antigen)

BLA STN# 125354/0 



 




Allermed Laboratories, Inc. submitted BLA (STN 125354) which was received on May 27, 2009. Initial review of the submitted information indicates that this submission is fileable. Deficiencies and further information requests will be addressed at a future date.

 

 
 

Firm:    Allermed Laboratories, Inc.

 

Document type: Review Memorandum

 

File name: 125354/0