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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVALS - September/October 1998

FDA Veterinarian Newsletter September/October 1998 Volume XIII, No V

Company

Generic and (Brand) Names

Indications

Routes/Remarks

Alpharma Inc.
(NADA 141-100)
Bacitracin Methylene Disalicylate, Decoquinate, Roxarsone (BMD, Deccox, 3-Nitro)Broiler chickens. To be used as an aid in the prevention of necrotic enteritis, for the prevention of coccidiosis, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.MEDICATED FEED: Roxarsone is a Category II drug. Formerly, a Medicated Feed Application (MFA) was required for feed mills to make Type C medicated feeds using Category II Type A medicated articles. Following passage of ADAA, a feed mill license is required. The feed is to be fed as sole ration and NOT fed to layers or breeders. It is to be withdrawn 5 days before slaughter. Access to drinking water should be provided at all times. Federal Register 7/17/98.
Alpharma Inc.
(NADA 141-085)
Bacitracin Methylene Disalicylate, Zoalene (BMD, Zoamix)Turkeys. To be used for prevention and control of coccidiosis, and for increased rate of weight gain and improved feed efficiency.MEDICATED FEED: For turkeys grown for meat purposes only, not to be fed to laying birds. Fed as sole ration until 14 to 16 weeks of age. Federal Register 7/20/98.
Alpharma Inc.
(NADA 141-088)
Bacitracin Methylene and Nitarsone (BMD, Histostat)Turkeys. To be used as an aid in the prevention of blackhead and for increased rate of weight gain and improved feed efficiency.MEDICATED FEED: For growing turkeys as sole ration. Adequate water must be provided near feeders at all times. Overdosage or lack of water may result in leg weakness or paralysis. Use to be discontinued 5 days before slaughter. Drug is dangerous for geese, ducks, and dogs. Federal Register 7/21/98
Pharmacia & Upjohn
(NADA 46-718)
Melengestrol Acetate
(dry form) (MGA) and Oxytetracycline (dry form) (OTC)
Confined heifers. For increased rate of weight gain, improved feed efficiency, suppression of estrus, and reduced incidence of liver abscesses.MEDICATED FEED: Only for heifers fed in confinement. Feed containing MGA 0.25 to 0.5 milligrams per head per day and 75 milligrams oxytetracycline per head per day. Do not mix liquid MGA with liquid oxytetracycline in a common liquid feed supplement. Federal Register 8/3/98.
Pharmacia & Upjohn (NADA 46-719)Melengestrol Acetate (MGA) (liquid form) and Oxytetracycline (dry form) (OTC)Confined heifers. For increased rate of weight gain, improved feed efficiency, suppression of estrus, and reduced incidence of liver abscesses.MEDICATED FEED: Only for heifers fed in confinement. Feed containing MGA 0.25 to 0.5 milligrams per head per day and 75 milligrams oxytetracycline per head
per day. Federal Register 8/3/98.
Boehringer Ingelheim Animal Health, Inc. (NADA 140-973)Clenbuterol HCl Syrup Rx (VENTIPULMIN)Horses. For the management of horses affected with airway obstruction such as occurs in chronic obstructive pulmonary disease(COPD).ORAL: Administer twice a day. Treat at effective dose for 30 days. The effect on breeding stallions and brood mares has not been determined. At end of 30 day treatment period drug should be withdrawn. Federal law prohibits the extra-label use of this drug in food animals. Federal Register 8/4/98.