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Vaccines, Blood & Biologics

November 18, 2011 Approval Letter - ABBOTT ESA Chagas

Our STN: BL 125361/23

Abbott Laboratories
Attention: Ms. Susan Sanborn
Diagnostics Division, D-49C/AP6C/2
100 Abbott Park Road
Abbott Park, IL 60064-6092
Dear Ms. Sanborn:
We have approved your request to supplement your biologics license application for Trypanosoma cruzi (E. coli, Recombinant) Antigen to include an in vitro enzyme strip assay intended for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum and plasma specimens.  The assay is intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed screening test for antibodies to T. cruzi.
You are approved to manufacture Trypanosoma cruzi (E. coli, Recombinant) Antigen at the following facilities: Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, FEI Number 1415939; and-------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. The final formulated product will be manufactured, filled, assembled, labeled, and packaged --------------------(b)(4)-----------------------------------------, and final testing will be performed at Abbott Park, Illinois. You may label your product with the proprietary name ABBOTT ESA Chagas, and market it as approved in your license application.
The dating period for Trypanosoma cruzi (E. coli, Recombinant) Antigen shall be 18 months from the date of manufacture when stored at 2-8 °C. The date of manufacture shall be defined in accordance with 21 CFR 610.50. The expiration date for the packaged product, ABBOTT ESA Chagas, shall be dependent on the shortest expiration date of any component. 
Please submit samples of the product ABBOTT ESA Chagas 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 Biologics 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 Trypanosoma cruzi (E coli, Recombinant) Antigen or in the manufacturing facilities.
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 submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide a PDF electronic copy as well as three original paper copies for circulars and other labels.
In addition, two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with a Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.
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)].
You must submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by 21 CFR 600.80(k)(2). Since your product is characterized as a device as well as a biological, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A. Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002..   
Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.  
We acknowledge your written commitments as described in your amendment of August 18, 2011 and your amendment of November 16, 2011 as outlined below:
1.      --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------
Please label the submission with the following designator: Postmarketing Study Commitment – Final Study Report
2.      ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Please label the submission with the following designator: Postmarketing Study Commitment – Final Study Report
For each postmarketing commitment not subject to the reporting requirements of 21 CFR 601.70, you may report the status to FDA as a “PMC Submission – Status Update.” The status report for each commitment should include:
  • The original schedule for the commitment, and
  • The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).
Additionally, while not a post-market commitment, we note that you have voluntarily agreed to --------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sincerely yours,
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research


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