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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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