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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Statement on Animal Pharmaceutical Industry Response to Guidance #213

Updated March 19, 2014

On December 12, 2013, as part of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, FDA asked the animal pharmaceutical industry to notify the agency in writing within 90 days of its intent to engage with FDA as defined in Guidance #213. This final guidance lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications and place therapeutic uses under veterinary oversight.

As of March 12, 2014, FDA has received responses from all of the sponsors affected by this guidance and is currently reviewing and analyzing those responses. We are encouraged by the positive response thus far. We will issue a more detailed update later this month concerning the sponsors that have committed to seeking withdrawal of approval relating to production uses and changing the marketing status of their products from over-the-counter to use by Veterinary Feed Directive or prescription. FDA intends to keep the public apprised of progress.

On March 19, 2014, FDA announced the withdrawal of approval of a new animal drug application and two abbreviated new animal drug applications for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. These products were approved for increased weight gain and improved feed efficiency in swine. These approvals were held by Zoetis Inc., which requested that FDA withdraw approval of the products’ applications because they are no longer manufactured or marketed.

The specific new animal drug applications being withdrawn are for the following products:

NADA 039-077: CSP 250 (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article
ANADA 200-140: AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article
ANADA 200-167: AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article

The withdrawals will be effective ten calendar days after publication in the Federal Register on March 20, 2014.