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Schering-Plough receives first U.S. approval for AQUAFLOR® antibiotic
Published:  14 November, 2005

SCHERING-Plough Corporation has announced its Animal Health Division has received approval from the U.S. Food and Drug Administration (FDA) to begin marketing AQUAFLOR® (florfenicol) in the United States for the control of mortality in catfish due to enteric septicemia (ESC) of catfish associated with Edwardsiella ictaluri.

AQUAFLOR is a highly palatable, fast-acting antibiotic proven worldwide to be effective against a wide range of bacteria in several aquatic species. It is the first in-feed antibiotic to be approved for U.S. aquaculture in more than 20 years. AQUAFLOR’s sister product, NUFLOR® (florfenicol), has been used successfully in the United States since 1996 to treat respiratory disease in beef and non-lactating dairy cattle.

After reviewing data on AQUAFLOR, the FDA’s Center for Veterinary Medicine (CVM) concluded that the meat derived from catfish that were fed florfenicol is safe for human consumption when the fish are fed according to the approved label.

The agency also determined that AQUAFLOR can be used in food-producing animals without creating a public health risk from antimicrobial resistance. The product is limited to use by veterinarians, a condition that will reduce the likelihood of resistance developing.

Aquaflor has been used to treat fish species around the world since the early 1990s. Its first introduction was in Japan for use in yellowtail and other local species. The antibiotic was subsequently introduced in Europe, Canada and Chile for the treatment of furunculosis in salmon. Additional approvals have been granted or are anticipated over the next few months in Latin American and Far East countries for shrimp and species of finfish such as tilapia. Additional claims and indications are also being sought in Europe as well. Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products.

www.fishupdate.com is published by Special Publications. Special Publications also publish European Fish Trader, Fishing Monthly, Fish Farming Today, Fish Farmer, the Fish Industry Yearbook, the Scottish Seafood Processors Federation Diary, the Fish Farmer Handbook and a range of wallplanners.


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