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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVALS - March/April 1999

FDA Veterinarian Newsletter March/April 1999 Volume XIV, No II

CompanyGeneric and Brand NamesIndicationsRoutes/Remarks

Boehringer Ingelheim Vetmedica, Inc.

(NADA 141-002)

Oxytetracycline HydrochlorideBeef and Dairy calves. For control and treatment of oxytetracycline sensitive diseases, bacterial enteritis, and bacterial pneumonia.ORAL: The NADA provides for use of 500 and 1000 milligram calf boluses to control and treat bacterial diseases caused by organisms sensitive to oxytetracycline, bacterial enteritis caused by Salmonella typhimurium and Escherichia coli, and bacterial pneumonia caused by Pasteurella multocida. Federal Register: 12/21/98.

Novartis Animal Health US, Inc.

(NADA 141-120)

Clomipramine Hydrochloride (ClomicalmTM) RxDogs. To be used as a part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than6 months of age.

ORAL: The NADA provides for administration of tablets as a single daily dose or divided twice daily to dogs greater than 6 months of age at 0.9 to 1.8 mg per pound per day.

Federal Register:1/12/99.

Elanco Animal Health, Division of Eli Lilly & Co.

(NADA 140-926)

Narasin/Nicarbazin and Bacitracin Methylene Disalicylate (Maxiban®, BMD® )Broiler chickens. For prevention of certain forms of coccidiosis and for increased rate of weight gain and improved feed efficiency.

MEDICATED FEED: The NADA provides for combining approved Narasin/nicarbazin (1:1 fixed ratio) and BMD® Type A medicated articles to make combination Drug Type C medicated broiler chicken feeds for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E.acervulnia, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency. This NADA requires manufacture in a licensed feed mill.

Federal Register:02/02/99.