Vaccines, Blood & Biologics
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Filing Notification Letter - Spherusol
Our STN: BL 125354/0
Allermed Laboratories, Inc.
Attention: H.S. Nielsen, Jr., Ph.D.
7203 Convoy Court
San Diego, CA 92111
Dear Dr. Nielsen:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated May 26, 2009, for Coccidioides immitis Spherule-Derived Skin Test Antigen, to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is
March 27, 2010. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than February 25, 2010. If post marketing study commitments (506B) are required, we will contact you no later than
February 25, 2010.
While conducting our filing review, we identified potential review issues and will be communicating them to you on or before August 9, 2009.
If you have any questions, please contact the Regulatory Project Manager, Dr. Jon Daugherty, at (301) 827-3070.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research