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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - July/August 1999

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

CompanyGeneric & (Brand) NamesIndicationsRoutes/Remarks
Fort Dodge Animal Health
(NADA 141-043)
Trenbolone Acetate and Estradiol Benzoate (Synovex®Plus TM)Cattle - steers fed in confinement for slaughter. For increased rate of weight gain.SUBCUTANEOUS: In the supplemental NADA, the increased rate of weight gain is added to the already approved use for improved feed efficiency. An ADI for trenbolone is established at 0.4 microgram per kilogram of body weight per day. Federal Register: 04/15/99.
Boehringer-Ingelheim Vetmedica, Inc.
(NADA 48-271)
Dichlorvos (Task®) RxDogs and Cats. For the removal and control of certain intestinal roundworms and hookworms.ORAL: The supplemental NADA adds additional tablet sizes. Adds use in cats and puppies in addition to approved use in dogs and kittens. Federal Register: 04/15/99.
Fleming Laboratories, Inc.
(NADA 10-005)
PiperazineChickens, Turkeys, and Swine. For the treatment of certain parasitic infections.ORAL: NAS/NRC DESI supplement reflects compliance with review and FDA conclusions based on review. A tolerance of 0.1 ppm for piperazine in edible tissues of poultry and swine is established. Federal Register: 04/29/99.
PennField Oil Co.
(NADA 138-935)
Chlortetracycline HydrochlorideCattle. For the treatment of bacterial enteritis and bacterial pneumonia.MEDICATED FEED: The supplement provides for a revised withdrawal period of 1-day following feeding of Type B and Type C chlortetracycline feeds to cattle.
Federal Register: 05/03/99.
Merial Ltd.
(NADA 128-409)
Ivermectin (Ivomec®)Cattle. For 28-day persistent control of lungworms in addition to use for control and treatment of various parasites and various persistent uses.INTRAMUSCULAR: The supplement provides for the increase from 21 days. A tolerance for ivermectin residues in cattle muscle of 10 ppb is established. Federal Register: 05/17/99.
Merial Ltd.
(NADA 140-833)
Ivermectin Clorsulon (Ivomec® Plus)Cattle. For 28-day persistent control of lungworms in addition to use for control and treatment of various parasites and various persistent uses.INTRAMUSCULAR: The supplement provides for the increase from 21 days. A tolerance for Ivermectin residues in cattle muscle of 10 ppb is established. Federal Register: 05/17/99.
Roche Vitamins, Inc.
(NADA 40-209)
Sulfadimethoxine Ormetoprim (Rofenaid®40)Chukar partridge. For the prevention of coccidiosis.MEDICATED FEED: The supplement provides for the use of Rofenaid?40 Type A medicated articles to make Type C chukar partridge feeds. Also, tolerances of 0.1 ppm each are established for sulfadimethoxine and ormetoprim residues in edible chukar partridge tissues. Federal Register: 05/17/99.
Hoechst Roussel Vet (NADA 131-675)FenbendazoleSwine. Revised feeding instructions to allow for restricted feeding of sows.MEDICATED FEED: The supplement provides clarification of the amount of the drug in Type C medicated swine feeds to be fed to the animals for treatment. Federal Register: 05/18/99.
Schering-Plough Animal Health Corp. (NADA 30-315)Selenium, Vitamin E InjectionHorses, dogs, cattle, sheep, swine.SUBCUTANEOUS: The supplement provides for removing from the specifications of those ingredients other than the active ingredients. Federal Register: 05/24/99.