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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 19, 2013 Approval Letter - Anti-B (Murine Monoclonal)

DIAGAST
Attention:  Ms. Marcia Palma
c/o NAMSA
4050 Olson Memorial Highway, Suite 450
Minneapolis, MN  55422

Dear Ms. Palma:

We have approved your biologics license applications for the following biological products effective this date:

STN                              Name of Biological Products 

BL 125435/0

Blood Grouping Reagent, Anti-B (Murine Monoclonal)(For Further Manufacturing Use)

BL 125442/0

Blood Grouping Reagent, Anti-D (Human Monoclonal) (IgM) (For Further Manufacturing Use)

BL 125443/0

Blood Grouping Reagent, Anti-E (Human Monoclonal)(For Further Manufacturing Use)

You are hereby authorized to introduce or deliver for introduction into interstate commerce, the biological products listed above under your existing Department of Health and Human Services U.S. License No. 1744.  The Blood Grouping Reagents (For Further Manufacturing Use) listed above are indicated for use in the manufacture of Blood Grouping Reagents, Anti-B, Anti-D and Anti-E by Diagnostic Grifols S.A. (Spain) U.S. License No. 1887, to produce in vitro product Blood Grouping Reagents (BGR) under a shared manufacturing arrangement.

Under this authorization, you are approved to manufacture the products listed above at your facility in Loos, France.  You must label your products with the proper names that we have approved, and market them as approved in your license applications.

We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

The dating period for the products listed above shall be 24 months from the date of manufacture when stored at 2-8 ºC.  The date of manufacture shall be defined as the date of the final ------------(b)(4)---- prior to the filling operation. 

You currently are not required to submit samples of future lots of the products listed above to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2.  We will continue to monitor compliance with 21 CFR 610.1 requiring completion of tests for conformity with standards applicable to each product prior to release of each lot.

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.

ADVERSE EVENT REPORTING

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, Maryland 20847-3002.

AGREED UPON POSTMARKETING COMMITMENTS

We acknowledge your written commitment as described in your letter of April 8, 2013, as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.  

  1. DIAGAST commits to perform a revalidation of the ---(b)(4)--- method per --(b)(4)-- for ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.  DIAGAST will submit the results to FDA as a Postmarketing Study Commitment – Final Study Report by September 5, 2013.

We request that you submit information concerning nonclinical and chemistry, manufacturing, and control postmarketing commitments and final reports to your BLAs, STN BL 125435/0, 125442/0, and 125443/0.

Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:

  • Postmarketing Study Correspondence
  • Postmarketing Study Commitment – Final Study Report
  • Supplement Contains 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).

When you have fulfilled your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.

Sincerely yours,

Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics
Evaluation and Research