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Animal & Veterinary

FDA Approves HALAMID Aqua to Treat Disease in Freshwater Fish

May 6, 2014

The U.S. Food and Drug Administration (FDA) has approved HALAMID® Aqua, a chloramine-T powder for immersion, to treat bacterial gill disease in freshwater-reared salmonids, external columnaris disease in walleye, and external columnaris disease in freshwater-reared warm water finfish. HALAMID Aqua is a designated drug under the Minor Use Minor Species Act (MUMS Act). The MUMS Act is intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species.

In evaluating HALAMID® Aqua, the FDA reviewed extensive data to ensure the product met all necessary effectiveness, target animal safety, human food safety, manufacturing, and environmental impact standards. The FDA has concluded that fish treated with chloramine-T are safe for human consumption when the fish are treated according to the approved labeling.

The approval of HALAMID® Aqua is the result of coordinated efforts between the pharmaceutical company, Axcentive SARL, and public sector partners, including the Association of Fish and Wildlife Agencies, the Federal Interagency Working Group on Aquaculture, U.S. Department of Agriculture, U.S. Fish and Wildlife Service, and U.S. Geological Survey Upper Midwest Environmental Sciences Center.

HALAMID® Aqua is a product of Axcentive SARL of France and is distributed by Western Chemicals of Ferndale, Washington. HALAMID® Aqua for the approved indications was designated under the Minor Use and Minor Species Animal Health Act.

Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7519 Standish Place, HFV-1

Rockville, MD 20855

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