April 30, 2001
APPROVAL WITHDRAWN FOR ABBOTT LABORATORIES' POULTRY FLUOROQUINOLONE DRUGS
Effective April 30, 2001, FDA's Center for Veterinary Medicine (CVM) withdrew the approvals of two new animal drug applications (NADAs) sponsored by Abbott Laboratories. The NADAs provide for use of sarafloxacin antimicrobial drugs to treat poultry. One is NADA 141-017 for SaraFlox® (sarafloxacin hydrochloride) WSP, a water-soluble powder used in the drinking water of broiler chickens and growing turkeys for control of mortality associated with Escherichia coli. The other is NADA 141-018 for SaraFlox® (sarafloxacin hydrochloride) Injection; an injectable solution used in 18-day embryonated broiler eggs and day-old broiler chickens for control of early chick mortality associated with E. coli.
Last year, CVM informed Abbott Laboratories that, on the basis of new data and information before it, there is a question of human food safety -- the potential for the development of resistant organisms -- due to the use of fluoroquinolones such as sarafloxacin in poultry. Specifically, that CVM has determined that:
The use of fluoroquinolones in poultry causes the development of fluoroquinolone-resistant Campylobacter, a pathogen to humans, in poultry;
This fluoroquinolone-resistant Campylobacter is transferred to humans and is a significant cause of the development of fluoroquinolone-resistant Campylobacter infections in humans; and
Fluoroquinolone-resistant Campylobacter infections are a hazard to human health.
Fluoroquinolones also are approved for use in humans, and they are considered to be one of the most valuable antimicrobial drug classes available to treat human infections because of their spectrum of activity, safety, and ease of administration. This class of drugs is effective against a wide range of human diseases and is used both in treatment and prophylaxis of bacterial infections in the community and in hospitals. Fluoroquinolones are used routinely by physicians for the treatment of foodborne disease. These diseases have a major public health consequence in the United States. After being informed by CVM of this human food safety question, Abbott Laboratories requested voluntary withdrawal of approval of NADAs 141-017 and 141-018.
Additional information about this withdrawal is available in the April 30, 2001, Federal Register, and from Dr. Mohammad I. Sharar, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0159. Information about CVM's concern about antimicrobial resistance may be found on the CVM Home Page.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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