[Federal Register: April 30, 2001 (Volume 66, Number 83)]
[Notices]
[Page 21400-21401]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap01-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0170]
Abbott Laboratories' Sarafloxacin for Poultry; Withdrawal of
Approval of NADAs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing
approval of two new animal drug applications (NADAs) sponsored by
Abbott Laboratories. The NADAs provide for use of sarafloxacin to treat
poultry. In a final rule published elsewhere in this issue of the
Federal Register, FDA is amending the animal drug regulations
by removing the portions reflecting approval of these NADAs.
DATES: Withdrawal of approval is effective April 30, 2001.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center
for Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0159.
SUPPLEMENTARY INFORMATION: Abbott Laboratories, North Chicago,
IL 60064, is sponsor of the following NADAs: (1) NADA 141-017
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 in (21 CFR 520.2095); and (2) NADA 141-018
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 (21 CFR 522.2095).
The sponsor was informed by FDA that, on the basis of new data and
information before it, there is a question of human food safety, due to
the use of fluoroquinolones such as sarafloxacin in poultry. After
being informed by FDA of this question, Abbott Laboratories requested
voluntary withdrawal of approval of NADAs 141-017 and 141-018. By doing
so, the firm waived its opportunity for hearing.
Therefore, under authority delegated to the Commissioner of Food
and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary
Medicine (21 CFR 5.84),
[[Page 21401]]
and in accordance with Sec. 514.115 Withdrawal of approval of
applications (21 CFR 514.115), notice is given that approval of
NADAs 141-017 and 141-018, and all supplements and amendments thereto
is hereby withdrawn effective April 30, 2001. Any new animal drug
product that is not the subject of an approved application is subject
to regulatory action at any time.
In a final rule published elsewhere in this issue of the
Federal Register, FDA is amending the animal drug regulations
to reflect the withdrawal of approval of these NADAs.
Dated: April 17, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-10067 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S