FDA Announces the Availability of Safety and Effectiveness Data to Support a New Animal Drug Application for Aquaculture

The Food and Drug Administration (FDA) is announcing the availability of Public Master Files (PMFs) containing safety and effectiveness information to support a new animal drug application (NADA) for use of chloramine-T for the control of columnaris disease and bacterial gill disease in certain freshwater finfish.

Information in or referenced in the PMF may be used by pharmaceutical sponsors (at no cost) to support the approval of this drug. Sponsors need to supply the additional manufacturing, environmental, human food safety, and other required information, as well as labeling, to constitute a complete NADA. Today’s announcement is not for the approval of this drug – only that information is available to support an effectiveness, target animal safety, and parts of a human food safety technical section of a pharmaceutical sponsor’s NADA.

Specifically, information is available regarding the effectiveness of chloramine-T for the following:

  • Control of mortality in freshwater-reared salmonids due to bacterial gill disease (BGD) associated with Flavobacterium psychrophilum
  • Control of mortality in walleye and all warmwater finfish due to external columnaris disease associated with Flavobacterium columnare

The information reviewed also demonstrates the target animal safety of this drug for all freshwater-reared finfish. Public information to support parts of the human food safety technical section of an NADA for chloramine-T is summarized in these PMFs.

The information, contained in Public Master Files (PMF) 5893 and 5637, was compiled by the United States Fish and Wildlife Service’s Aquatic Animal Drug Approval Partnership Program and the United States Geological Survey’s Upper Midwest Environmental Sciences Center. These national research programs facilitate generation of data to support FDA approval of new animal drugs for aquatic species.

For questions or further information, please contact: Cindy Burnsteel, Center for Veterinary Medicine (HFV"130), FDA, 7500 Standish Pl., Rockville, MD 20855, 240"276"8341, cindy.burnsteel@fda.hhs.gov.


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