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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVALS - July/August 1999

FDA Veterinarian Newsletter July/August 1999 Volume XIV, No IV

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks:
Merial Ltd.
(NADA 141-123)
Omeprazole (GastroGard®) RxHorses and foals 4 weeks of age and older. For the treatment and prevention of gastric ulcers.ORAL: For treatment of gastric ulcers, 1.8 milligrams of omeprazole per pound of body weight once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 milligram per pound of body weight once a day for another 4 weeks. Do not use in horses intended for human consumption.
Federal Register: 04/15/99.
Alpharma, Inc.
(NADA 141-112)
Narasin/Nicarbazin (Maxiban TM) Bacitracin Methylene Disalicylate (BMD®) Roxarsone (3-Nitro®)Broiler chickens. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased weight gain, improved feed efficiency, improved pigmentation.MEDICATED FEED: The NADA provides for using approved narasin and nicarbazin, bacitracin methylene disalicylate, and roxarsone Type A medicated articles to make Type C medicated broiler chicken feeds. This use of Type A medicated articles to make Type C medicated feeds is limited to manufacture in a licensed feed mill.
Federal Register: 04/15/99.
Elanco Animal Health, Division of Eli Lilly and Co. (NADA 141-113)Narasin/Nicarbazin (Maxiban®), Roxarsone (3-Nitro®)Broiler chickens. For prevention of coccidiosis, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.MEDICATED FEED: The NADA provides for combining approved narasin/nicarbazin and roxarsone Type A medicated articles to make combination drug Type C medicated broiler chicken feeds. This use of Type A medicated articles to make Type C medicated feeds is limited to manufacture in a licensed feed mill.
Federal Register: 04/26/99.
Roche Vitamins, Inc.
(NADA 141-109)
Lasalocid, Bacitracin ZincTurkeys. For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides, and for increased rate of weight gain and improved feed efficiency.MEDICATED FEED: The NADA provides for the use of 20 percent of lasalocid Type A medicated articles and bacitracin zinc Type A medicated articles containing 50 grams per pound bacitracin activity in making Type C medicated feed containing 68-113 g/ton lasalocid and 4-50 g/t bacitracin zinc.
Federal Register: 05/18/99.