
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 You may refer to the draft Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names for further information.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.