NEWS
08/18/1995

<TITLE>FDA APPROVES FLUOROQUINOLONE ANTIBIOTIC FOR POULTRY</TITLE>
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P95-5                                Food and Drug Administration 
FOR IMMEDIATE RELEASE                Donald McLearn (301) 827-6242 


       FDA APPROVES FLUOROQUINOLONE ANTIBIOTIC FOR POULTRY

     The Food and Drug Administration today approved a
fluoroquinolone antibiotic, sarafloxacin, for use in poultry
drinking water to control illnesses caused by E. coli bacteria. 
Sarafloxacin is the first fluoroquinolone approved for use in food
animals.
     Fluoroquinolones are the newest class of antibiotics developed
for treating infections in people and animals.  Another
fluoroquinolone drug, enrofloxacin, was approved in 1989 to treat
certain infections in pet animals.  
      "Sarafloxacin provides veterinarians a way of preventing
disease in poultry flocks as long as it is used appropriately,"
said Commissioner of Food and Drugs David A. Kessler, M.D.  "It is
important that antibiotics for food animals be used correctly to
minimize the potential for development of drug-resistant microbes." 
      At a public hearing in May 1994, FDA convened its Veterinary
Medicine and Anti-infective Drugs Advisory Committees to consider
whether use of fluoroquinolones as animal drugs would increase
chances of development of drug-resistant bacteria.  The committees
recommended that FDA approve fluoroquinlones found to be safe and 
                             -more-

                                 P95-5, Page 2, Fluoroquinolone
effective for animal use, but also recommended that the agency
establish appropriate conditions of approval to minimize any
potential for development of resistant bacteria. 
       FDA is cooperating with the U.S. Department of Agriculture
and the Centers for Disease Control in a monitoring program to
detect and prevent disease resistant microbes.  Under the program,
USDA periodically will test salmonella samples from animals for
continued susceptibility to antimicrobial drug products.  CDC will
conduct similar testing on samples of human salmonella and E. coli. 
The manufacturer will test samples of animal E. coli to measure
emergence of any resistance in the drug's target organism.   
     In addition, FDA's Center for Veterinary Medicine will conduct
educational programs for the industry and veterinarians in the
appropriate use of the product. 
     Sarafloxacin, which will be available only through a
prescription, is manufactured by Abbott Laboratories of North
Chicago, Ill., and is distributed under the trade name Saraflox.
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