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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM has published in the Federal Register notice of the approval of these Supplemental New Animal Drug Approvals

FDA Veterinarian Newsletter September/October 2004 Volume XIX, No V

AGRIMYCIN 166 (Oxytetracycline hydrochloride) Soluble Powder filed by Agri Laboratories, Ltd. (ANADA 200-066). The product is for use in chickens, turkeys and swine to make medicated drinking water for the treatment of various bacterial diseases of livestock. The supplemental NADA provides for a new package size (9.87 oz. [280 g]) and change of strength of oxytetracycline. The product is approved in chickens for control of infectious synovitis caused by Mycoplasma synoviae; for control of respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum, and Escherichia coli; and for control of fowl cholera caused by Pasteurella multocida; in turkeys for control of Hexamitiasis caused by Hexamita meleagridis; control of infectious synovitis caused by Mycoplasma synoviae, and in growing turkeys for control of complicating bacterial organisms associated with bluecomb (transmittal enteritis, coronaviral enteritis); and in swine for the control and treatment of the following diseases: bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis; bacterial pneumonia caused by Pasteurella multocida; and in breeding swine for leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona. Notice of approval was published August 11, 2004.