Withdrawal of Approval of New Animal Drug Applications: Coumaphos; Novobiocin; Buquinolate and Lincomycin

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Federal Register: May 5, 2010 (Volume 75, Number 86)

Notices

Page 24719-24720

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr05my10-105

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.

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: john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following sponsors have requested that

FDA withdraw approval of the three NADAs listed in Table 1:

Table 1.

NADA No./Product

21 CFR Cite

Sponsor

(Established Name of

(Sponsor's Drug

Drug)

Labeler Code)

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

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

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)

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is given that approval of NADAs 13-467, 42-117, and 45-738, and all supplements and amendments thereto, is hereby withdrawn, effective May 17, 2010.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

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