• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

Revised Labeling For Some Medicated Feed Products

January 30, 1997

The approved conditions of use for Type A medicated articles containing chlortetracycline and oxytetracycline have changed as a result of the approval of several supplemental new animal drug applications (NADAs) in accordance with findings of the National Academy of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI) effectiveness evaluations and the approval of "me-too" NADAs that were dependent upon the DESI-finalization. Products affected by this change include:

ProductSponsorNADA Number
Chlortetracycline
Type A Medicated Articles
Hoffman La Roche, Inc. (formerly held by American Cyanamid)NADA 48-761
 Pfizer, Inc.NADA 92-286 and NADA 92-287
 ALPHARMA (formerly A.L. Labs.)NADA 46-699
 ADM Animal Health & Nutrition Division (formerly Feed Specialties Co.)NADA 48-480
 PennField Oil Co.NADA 138-935

Indications

Chickens, Turkeys, Swine, Sheep, Calves, Beef and Non-Lactating Dairy Cattle. For improved production efficiency, and for control and treatment of various bacterial diseases susceptible to chlortetracycline (CTC.)

ProductSponsorNADA Number
Oxytetracycline
Type A Medicated Articles
Pfizer, Inc.NADA 8-804
NADA 95-143
 PennField Oil Co.NADA 138-938

Indications

Chickens; Turkeys; Swine; Sheep; Calves, including veal calves; Beef and Non-Lactating Dairy Cattle, Bees, Fish, and Lobsters. For increased rate of weight gain, improved feed efficiency, and control and treatment of various bacterial diseases susceptible to oxytetracycline (OTC).

Manufacturers of these Type A articles have until April 1, 1997, to revise labeling to comply with the new conditions of use and to cease marketing any of these products bearing unrevised labeling. Similarly, mills manufacturing feed incorporating these Type A articles have until April 1, 1997, to use up existing stocks of labeling, and to print and begin using revised labeling.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855