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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVAL - November/December 1998

FDA Veterinarian Newsletter November/December 1998 Volume XIII, No VI

CompanyGeneric and (Brand) Names

Indications

Routes/Remarks

Alaco, Inc.
(NADA 141-107)
Beta-Aminopropionitrile Fumarate (Bapten) RxHorses. For the treatment of superficial digital flexor tendinitisINTRATENDINOUS:
The NADA provides for treatment of tendinitis of the superficial digital flexor tendon (SDFT) in the adult horse where there is sonographic evidence of fiber tearing. Do not use in breeding animals. Not for use in horses intended for food. Federal Register 8/19/98.
Peptech Animal Health Pty, Ltd. (NADA 141-044)Deslorelin Acetate (Ovuplant) RxHorses and Ponies. For inducing ovulation in estrous mares with an ovarian follicle greater than 30 mm in diameter.SUBCUTANEOUS:
T he NADA provides for inducing ovulation within 48 hours. One implant per mare. Not for use in horses intended for food. Federal Register 8/19/98.
Bayer Corp. Agriculture Division, Animal Health
(NADA 141-068)
Enrofloxacin Sol.
(Baytril 100) Rx
Cattle. For the treatment of bovine respiratory disease. Extra-label use in food-producing animals is prohibited.SUBCUTANEOUS:
A tolerance for Enrofloxacin residues in cattle is set. Do not inject more than 20 ml. at each site. Do not slaughter within 28 days of last treatment. Do not use in cattle intended for dairy production. Do not use in calves to be processed for veal. Federal Register 9/14/98.
Fort Dodge Animal Health
(NADA 141-108)
Etodolac Tabs.
(Etogesic) Rx
Dogs. For the management of pain and inflammation associated with osteoarthritis.ORAL -
Federal Register 9/25/98.
Alpharma Inc.
(NADA 141-102)
Bacitracin Methylene Disalicylate and Decoquinate (BMD)(Deccox)Broiler chickens. For prevention of coccidiosis, and for increased rate of weight gain and improved feed efficiency.MEDICATED FEED:
Do not feed to laying chickens; feed continuously as sole ration. Federal Register 9/29/98.