03-17440. Notice of Approval of New Animal Drug Applications; Chlortetracycline

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: [e-mail].

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.