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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review Memorandum, August 19, 2009 - Spherusol

  

Date:

August 19, 2009

To:

H.S. Nielsen, Jr., PhD
Allermed Laboratories, Inc.
From:
Catherine Miller
Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)
Through:
Ele Ibarra-Pratt, RN, MPH
Branch Chief, APLB
Subject:

Incomplete submission for evaluation of proposed proprietary name Coccidioidin SD
(Coccidioides immitis Spherule-Derived Skin Test Antigen)
BLA STN# 125354/0


 

We have examined the contents of your submission BLA STN# 125354 in our evaluation of your proposed proprietary name Coccidioidin SD.  
 
We find that the submission is incomplete because you omitted the following information:
  1. a list of all the likely care environments for dispensing and use of the product, such as whether the product is expected to be used in an inpatient/hospital setting, long-term care facility, clinic, doctor’s office, or home
  2. the proposed distribution of the product, such as whether the product is to be dispensed from a retail or hospital pharmacy setting or distributed directly from the manufacturer or select wholesaler
 
Please submit the information listed above as an amendment to BLA STN# 125354/0. The proprietary name review clock for this submission will not start until this information is submitted. You may refer to the draft Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names for further information.
 
If you have any questions with regards to this review please contact Catherine Miller, Consumer Safety Officer at 301-827-3028.