Incomplete Response Letter - Spherusol
Our STN: BL 125354
Allermed Laboratories, Inc.
Attention: H. S. Nielsen, Jr., Ph.D.
7203 Convoy Court
San Diego, CA 92111
Dear Dr. Nielsen:
We have received your September 15, 2010, amendment to your biologics license application submitted under section 351 of the Public Health Service Act for Coccidioides Immitis Spherule-Derived Skin Test Antigen (Spherusol).
We have determined that your amendment does not completely respond to our March 26, 2010, Complete Response (CR) Letter. As referenced in our Incomplete Response Letter dated August 26, 2010, we stopped the review clock. Because your September 15, 2010, submission is incomplete, we will not restart the clock until you address the following deficiency:
You state in your letter dated September 15, 2010, on page 5, that “Spherusol is indicated for use as a skin test antigen to detect cellular hypersensitivity to C.immitis.” We require a clearer description of how Spherusol will be used in a clinical setting in order to assess if the product is safe and effective under the indicated conditions of use. If this information is not available or is not sufficient to support a labeled indication for this product, further discussion and clinical studies may be necessary.
When submitting revised information e.g., labeling changes, to your BLA, we request that you provide a paginated copy containing tracked changes in order to facilitate CBER’s review of the revised documents.
Please be advised that, as stated in 21 CFR 601.3(c), if we do not receive your complete response within one year of the date of this letter, we may consider your failure to resubmit to be a request to withdraw the supplement. Reasonable requests for an extension of time in which to resubmit will be granted. However, failure to resubmit the supplement within the extended time period may also be considered a request for withdrawal of the supplement.
If you have any questions, please contact the Regulatory Project Manager (RPM), Ms. Holly Wieland 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