July 14, 2008


US approves two new antimicrobials for fish


The US Food and Drug Administration (FDA) has announce the approval of two new antimicrobials for aquaculture operations.


The two drugs would help stave off coldwater disease and columnaris disease.


The approval also allows for removal of the temperature limitation on previously approved salmonid indications, which restricted its use to water temperatures above 48.2 oF (9 deg C).


Terramycin 200 for Fish is the second drug approved for use during outbreaks of coldwater disease. Untreated, this disease can cause significant losses among salmonids at state and federal hatcheries including native species in restoration programs.


Terramycin 200 for Fish is the first drug approved for the control of mortality due to systemic columnaris disease associated with Flavobacterium columnare in freshwater-reared Oncorhynchus mykiss.
Oncorhynchus mykiss includes rainbow, steelhead, and redband trout, as well as other related subspecies. The bacterium can be a problem for trout and other fish when water temperatures are above 14 deg C.


FDA has concluded that fish fed oxytetracycline are safe for human consumption when the drug is administered according to the approved label directions.


Terramycin® 200 for Fish is a product of Phibro Animal Health, Ridgefield Park, New Jersey.


The drug is designated under the Minor Use and Minor Species Animal Health Act of 2004, which entitles Phibro Animal Health to seven years of exclusive marketing rights beginning on the date of approval.

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