November 22, 2005
Schering-Plough receives first US approval for AQUAFLOR® (florfenicol)
Schering-Plough Corporation recently announced its animal health division has received approval from the US 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 US 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 was safe for human consumption, when the fish were fed according to the approved label.
CVM said AQUAFLOR was reviewed under its Guidance for Industry 152 "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern."
The agency also determined that AQUAFLOR could 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 would reduce the likelihood of resistance developing.
Unlike sulfa drugs and tetracyclines, AQUAFLOR was developed specifically for use in food animal species. US studies showed that AQUAFLOR could be used with no setbacks in feed consumption or growth. AQUAFLOR's short 12-day withdrawal period leaves producers ample marketing flexibility.
"AQUAFLOR has proved to be safe and highly effective, with good palatability, so we have high hopes for it in the US aquaculture industry," said Dr. Patricia Gaunt, Associate Professor, Aquatic Animal Health, Mississippi State University College of Veterinary Medicine, said.
In tank trials conducted at Mississippi State University, catfish fingerlings challenged with ESC had a cumulative death rate of only 0.8 percent, compared with 60 percent for challenged, untreated fish. In the same study, treated fingerlings showed an infection rate of only 1.7 percent, compared with 72.3 percent for untreated controls.
Palatability trials showed that fish consumed feed medicated with AQUAFLOR at the same rate as unmedicated feed - even when AQUAFLOR was used at 10 times the recommended dose rate.
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. AQUAFLOR 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 several 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.
For more information on AQUAFLOR and other animal health products for aquaculture, please visit www.SPAQUACULTURE.com. More information on the new claim for US catfish may be obtained at www.AQUAFLOR-USA.com.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's website is www.spcorp.com. The animal health division is www.spah.com.
AQUAFLOR and NUFLOR are registered trademarks of Schering-Plough Veterinary Corporation.
