[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Page 41161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17440]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Notice of Approval of New Animal Drug Applications;
Chlortetracycline
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing notice
that in 2001 it approved a supplemental new animal drug application
(NADA) filed by Alpharma, Inc. The supplemental NADA provided for use
of chlortetracycline Type A medicated articles to make Type B and Type
C medicated swine feeds for the control of porcine proliferative
enteropathies (ileitis). The applicable section of the regulation did
not require amendment.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: In accordance with section 512(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR
514.105(a) and 514.106(a), FDA is providing notice that in 2001 it
approved a supplemental NADA that was not the subject of a final rule.
A final rule was not published because 21 CFR 558.128 did not require
amendment.
On November 15, 2001, FDA approved a supplement filed by Alpharma,
Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024 to NADA 48-
761 for AUREOMYCIN (chlortetracycline) Type A medicated articles. The
supplemental NADA provided for use of AUREOMYCIN Type A medicated
articles to make Type B and Type C medicated swine feeds for the
control of porcine proliferative enteropathies (ileitis) caused by
Lawsonia intracellularis susceptible to chlortetracycline. No new data
were submitted. The necessary amendment to 21 CFR 558.128 was made in a
final rule (65 FR 45881, July 26, 2000) for the 2000 supplemental
approval of the identical claim for Alpharma, Inc.'s CHLORMAX
(chlortetracycline) Type A medicated articles, approved under NADA 046-
699.
A freedom of information summary containing approved product
labeling may be seen in the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 25, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-17440 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S