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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - September/October 1998

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

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks
Hoechst Roussel (NADA 120-648)Fenbendazole Paste (Panacur) (Safe-Guard)Horses. For treatment of encysted mucosal cyanthostome larvae including early and late third stage, and fourth stage larvae.ORAL: The supplemental NADA provides for expanding the indications to include additional organisms. Federal Register 6/10/98.
Alpharma Inc. (NADA 46-666)Penicillin G ProcaineChickens, turkeys, pheasants, quail, swine. For improved feed efficiency and increased rate of weight gain.MEDICATED FEED: The supplemental NADA reflects the results of the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Implementation (DESI) review of the product’s effectiveness and FDA’s conclusions based on that review. Federal Register 7/2/98.
Pfizer, Inc. (NADA 46-668)Penicillin G ProcaineChickens, turkeys, pheasants, quail, swine. For improved feed efficiency and increased rate of weight gain.MEDICATED FEED: The supplemental NADA reflects the results of the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Implementation (DESI) review of the product’s effectiveness and FDA’s conclusions based on that review. Federal Register 7/2/98.
Western Chemical, Inc. (NADA 140-989)Formalin (Parasite-S)Finfish and finfish eggs. Provides for use of formalin in solution as a parasiticide in water of all finfish and a fungicide in water of all finfish eggs.TOPICAL: The supplement broadens the scope of the NADA from select fish and select fish eggs to all finfish and all finfish eggs. Federal Register 7/16/98.
Alpharma, Inc. (NADA 65-470)Bacitracin Methylene Disalicylate (BMD Soluble)Quail. To make a medicated drinking water for growing quail for prevention of ulcerative enteritis.DRINKING WATER: Used as sole source of drinking water, containing 400 milligrams of bacitracin per gallon. Federal Register 7/17/98.
Schering-Plough Animal Health Corp. (NADA 101-479)Flunixin Meglumine (Banamine Inj. Sol.) RxBeef cattle and non-lactating dairy cattle. For the control of pyrexia associated with bovine respiratory disease & endotoxemia, and control of the inflammation in endotoxemia.INTRAVENOUSLY or INTRAMUSCULARLY: The supplement adds use in certain cattle in addition to use in horses. In addition, a tolerance of 0.125 ppm in cattle liver and 0.025 ppm in muscle are established. An ADI of 0.72 micrograms per kilogram of body weight per day is also established. Federal Register 7/20/98.
Alpharma Inc. (NADA 46-592)Bacitracin Methylene Disalicylate (BMD)Replacement chickens. To be fed as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to BMD.MEDICATED FEED: The supplement adds new use in replacement chickens. Federal Register 7/31/98.
Schering-Plough Animal Health Corp. (NADA 141-063)Florfenicol Injection (Nuflor) RxCattle. For treatment of bovine respiratory disease.SUBCUTANEOUS: The supplement provides for the new route, a new dosage of 40 milligrams per kilogram body weight and a 38-day slaughter withdrawal time and a tolerance of 3.7 ppm for florfenicol amine in liver and 0.3 ppm in muscle. An ADI of 10 micrograms per kilogram body weight per day is also established. Federal Register 8/3/98.
Novartis Animal Health US, Inc. (NADA 141-084)Milbemycin Oxime/Lufenuron Tablets (Sentinel) RxDogs. For prevention and control of flea populations and prevention of heartworm disease, for control of hookworm, and for removal and control of adult roundworm and whipworm infections.ORAL: The supplement provides for use for dogs not less than 4 weeks of age and not less than 11 pounds of body weight. This new formulation qualifies for 3 years of marketing exclusivity. The tablets are administered once a month. Use a minimum of 0.5 milligram of milbemycin and 10 milligrams of lufenuron per kilogram of body weight. Federal Register 8/3/98.
Novartis Animal Health US, Inc. (NADA 140-915Milbemycin Oxime Tablets (SAFEHEART) RxDogs. For the prevention of heartworm disease caused by Dirofilaria immitis at a minimum dosage of 0.05 mg/lb. of body weight.ORAL: The supplement provides for use of a lower dose of milbemycin in treating dogs and puppies. A dose of 2.3 and 5.75 mg tablets monthly in dogs 4 weeks of age or older and 2 pounds or greater body weight. Do not use in puppies less than 4 weeks of age or less than 2 pounds body weight. Federal Register 8/3/98.