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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - May/June 2001

FDA Veterinarian Newsletter May/June 2001 Volume XVI, No III

Company Generic and (Brand) Names Indications Routes/Remarks

Elanco Animal Health
(NADA 104-646)
Monensin (Rumensin®), Tylosin (Tylan®)
Cattle. For prevention and control of coccidiosis, reduction of the incidence of liver abscesses, and improved feed efficiency.
MEDICATED FEED—The supplement provides for use of monensin and tylosin single-ingredient Type A medicated articles to make combination drug Type C medicated feeds for cattle fed in confinement for slaughter. The Type C medicated feeds are used for improved feed efficiency, prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii, and reduction of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.
Federal Register 03/05/01

Novartis Animal Health US, Inc.
(NADA 141-163)
Milbemycin Oxime (MilbemiteTM) Rx
Cats and kittens. To treat ear mite infections.
OTIC—The supplement provides for reducing the lower age limit from 8 weeks of age to 4 weeks of age and for repeating treatment one time, if necessary.Federal Register 03/08/01

Phoenix Scientific, Inc.
(NADA 094-170)
Phenylbutazone Tab and Bolus
Dogs and Horses. For relief of inflammatory conditions associated with the musculoskeletal system.
ORAL—The supplement provides for oral use of a 200-mg strength tablet for relief of inflammatory conditions associated with the musculoskeletal system.Federal Register 03/12/01

Elanco Animal Health
A Division of Eli Lilly & Co.
(NADA 12-491)
Tylosin phosphate (Tylan®)
Cattle. For the reduction of the incidence of liver abscesses.
MEDICATED FEED—This supplement provides for the use of tylosin phosphate Type A medicated articles to make liquid Type B medicated feeds which are, in turn, used to make dry Type C medicated feeds for reduction of the incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in beef cattle.
Federal Register 03/23/01

Elanco Animal Health
A Division of Eli Lilly & Co.
(NADA 104-646)
Monensin (Rumensin®), Tylosin (Tylan®)
Cattle. For the reduction of the incidence of liver abscesses, and for improved feed efficiency.
MEDICATED FEED—This supplement provides for use of Rumensin and Tylan Type A medicated articles to make liquid combination drug Type B medicated feeds which are, in turn, used to make dry Type C medicated feeds used for improved feed efficiency and reduction of the incidence of liver abscesses caused by F. necrophorum and (Corynebacterium) pyogenes in cattle fed in confinement for slaughter.
Federal Register 03/23/01