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Review Memorandum, August 19, 2009 - Spherusol
|August 19, 2009|
H.S. Nielsen, Jr., PhD
Allermed Laboratories, Inc.
Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)
Ele Ibarra-Pratt, RN, MPH
Branch Chief, APLB
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:
- 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
- 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 You may refer to the draft Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names for further information.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.