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U.S. Department of Health and Human Services

Animal & Veterinary

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Letter to Bimeda Inc. Regarding Iron Dextran

December 23, 2010

Ms. Linda Duple
Director, North American Regulatory Affairs
Bimeda Inc.
2836 Dolliver Park Avenue
Lehigh, Iowa 50557

Dear Ms. Duple:

This response addresses your letter dated October 20, 2010 to the Center for Veterinary Medicine requesting that the Food and Drug Administration (FDA) exercise discretion over the importation by Bimeda Inc. Lehigh, Iowa of 200 mg/ml Injectable Iron Dextran, Lots 1A001, 1A002, 1A003, 1A004, 1A005, 1B001, 1B002, 1B003, 1B004, 1B005, 1C001, 1C002, 1C003, 1C004, 1C005, 1C006, 1C007, 1C008, 1C009 and 1C010 manufactured by Bimeda-MTC Animal Health, 420 Beaverdale Road, Cambridge, Ontario, Canada, to be shipped up to and including February 28, 2011, for sale and use in the United States.

FDA has approved applications for injectable iron dextran for use in the prevention and treatment of iron deficiency in baby pigs. We have evaluated the situation as to the availability of an adequate supply of this medically necessary veterinary drug product, and we concur that there is a high probability that a shortage of FDA approved Injectable Iron Dextran product exists. We are, therefore, by copy of this letter, exercising discretion over the temporary importation and distribution only of the aforementioned lot numbers of Bimeda-MTC Animal Health 200 mg/ml Injectable Iron Dextran. Since FDA is exercising discretion over the importation of these lots of 200 mg/ml Injectable Iron Dextran into the United States, we are requesting that you immediately submit to the Center for Veterinary Medicine all reports involving product defects, adverse drug experiences, and other consumer complaints. Additionally, future discretion for the importation of 200 mg/ml Injectable Iron Dextran will be considered on a lot-by-lot basis, if and when you again request such a consideration.

We suggest you provide a copy of this letter to the FDA import monitor at whatever city is to be the port of entry for the importation of the product.

If you have any questions or need further assistance, please feel free to contact Marea Harmon, Consumer Safety Officer, at 240-276-9239.

Sincerely yours,

/s/ Neal Bataller, ME, DVM
Division of Compliance (HFV-230)
Center for Veterinary Medicine