July 29, 2011 Approval 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:
We have approved your biologics license application for Coccidioides immitis Spherule - Derived Skin Test Antigen, effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Coccidioides immitis Spherule - Derived Skin Test Antigen under your existing Department of Health and Human Services U.S. License No. 467. Coccidioides immitis Spherule - Derived Skin Test Antigen is indicated for the detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, with a history of pulmonary coccidioidomycosis.
The review of this product was associated with the following National Clinical Trial (NCT) number: NCT00690092.
Under this authorization, you are approved to manufacture Coccidioides immitis Spherule - Derived Skin Test Antigen at your facility in San Diego, California. You may label your product with the proprietary name Spherusol™. The product will be supplied in a multi-dose vial containing 1 mL of Spherusol™.
We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues, which would have benefited from an advisory committee discussion.
The dating period for Coccidioides immitis Spherule - Derived Skin Test Antigen drug product shall be 36 months from the date of manufacture when stored at 2º to 8ºC (36º to 46ºF). Pursuant to 21 CFR 610.53(d), the date of manufacture shall be defined as the date of initiation of the first valid potency test.
Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologic Evaluation and Research (CBER).
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in, including, but not limited to, the manufacturing, testing, packaging or labeling of Coccidioides immitis Spherule - Derived Skin Test Antigen, or in the manufacturing facility.
You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate.
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation
You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253
(21 CFR 601.12(f)(4)).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
ADVERSE EVENT REPORTING
You must submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and you must submit distribution reports as described in 21 CFR 600.81. You should submit postmarketing adverse experience reports and distribution reports to the Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology HFM-210, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Prominently identify all adverse experience reports as described in 21 CFR 600.80. Per 21 CFR 600.2(f), please refer to http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm106001.htm for updated mailing address information.
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. Because the biological product for this indication has an orphan drug designation, you are exempt from this requirement.
Norman W. Baylor, Ph.D.
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research