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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review Memorandum, June 18, 2009 - Spherusol

  

 

Date:

 
June 18, 2009
To:Holly Wieland, Regulatory Project Manager, OVRR/DVRPA
From: 
Catherine Miller
Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)
Product: 
Coccidioidin SD (Coccidioides immitis Spherule-Derived Skin Test Antigen)
BLA STN# 125354/0

 


Allermed Laboratories, Inc. submitted a BLA (STN 125354) that was received on May 27, 2009. From an advertising and promotional labeling perspective, this submission is fileable.