[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Notices]
[Pages 24719-24720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10567]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0002]
Withdrawal of Approval of New Animal Drug Applications;
Coumaphos; Novobiocin; Buquinolate and Lincomycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three 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 the single NADA of the three that is codified.
DATES: Withdrawal of approval is effective May 17, 2010.
[[Page 24720]]
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: The following sponsors have requested that
FDA withdraw approval of the three NADAs listed in Table 1:
Table 1.
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NADA No./Product 21 CFR Cite
Sponsor (Established Name of (Sponsor's Drug
Drug) Labeler Code)
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Pharmacia & Upjohn NADA 13-467/ALBAMIX Not codified
Co., a Division of Susceptibility Disks
Pfizer, Inc., 235 (novobiocin)
East 42d St., New
York, NY 10017
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Pharmacia & Upjohn NADA 45-738/LINCOMIX/ Not codified
Co., a Division of BONAID
Pfizer, Inc., 235 (lincomycin/buquinolate)
East 42d St., New
York, NY 10017
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Purina Mills, Inc., NADA 42-117/Purina 6 Day 558.185 (017800)
P.O. Box 66812, St. Worm-Kill Concentrate
Louis, MO 63166-6812 (coumaphos)
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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
13-467, 42-117, and 45-738, and all supplements and amendments thereto,
is hereby withdrawn, effective May 17, 2010.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 NADA 42-117.
Dated: April 30, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-10567 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S