[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Notices]
[Pages 65642-65643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27010]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0511]
Withdrawal of Approval of New Animal Drug Applications; Aklomide;
Levamisole Hydrochloride; Nitromide and Sulfanitran
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of eight new animal drug applications (NADAs). In a final rule
published elsewhere in this issue of the Federal Register, FDA is
amending the animal drug regulations to remove portions reflecting
approval of these NADAs.
DATES: Withdrawal of approval is effective November 5, 2010.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, a Division of
Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d
[[Page 65643]]
St., New York, NY 10017 has requested that FDA withdraw approval of the
eight NADAs listed in Table 1 of this document.
Table 1
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Established name of
NADA No. Product drug(s)
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NADA 11-141................. UNISTAT-2 Type A nitromide and
medicated article. sulfanitran
NADA 14-250................. NOVASTAT Type A aklomide and
medicated article. sulfanitran
NADA 34-536................. ALKOMIX Type A aklomide
medicated article. aklomide,
ALKOMIX-3 Type A sulfanitran, and
medicated article. roxarsone
NADA 34-537................. NOVASTAT-3 Type A aklomide,
medicated article. sulfanitran, and
roxarsone
NADA 35-388................. NOVASTAT-W Soluble aklomide and
Powder. sulfanitran
NADA 39-666................. UNISTAT-3 Type A nitromide,
medicated article. sulfanitran, and
roxarsone
NADA 44-015................. TRAMISOL Type A levamisole
medicated article.
NADA 45-455................. TRAMISOL Type A levamisole
medicated article.
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Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
11-141, 14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and
all supplements and amendments thereto, is hereby withdrawn, effective
November 5, 2010.
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: October 8, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-27010 Filed 10-25-10; 8:45 am]
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