January 30, 1997
REVISED LABELING FOR SOME MEDICATED FEED PRODUCTS
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:
Product Sponsor NADA Number
Chlortetracycline Hoffman La Roche, Inc. NADA 48-761
Type A Medicated (formerly held by American Cyanamid)
Articles
Pfizer, Inc. NADA 92-286
and NADA 92-287
ALPHARMA (formerly A.L. Labs.) NADA 46-699
ADM Animal Health & Nutrition NADA 48-480
Division
(formerly Feed Specialties Co.)
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.)
Product Sponsor NADA Number
Oxytetracycline Pfizer, Inc. NADA 8-804
Type A Medicated NADA 95-143
Articles
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.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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