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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - May/June 1999

FDA Veterinarian Newsletter May/June 1999 Volume XIV, No III

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks
Schering-Plough Animal Health Corp. (NADA 141-063)Florfenicol
(Nuflor® ) solution Rx
Cattle. For treatment of foot rot.SUBCUTANEOUS: For treatment of cattle for bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Federal Register: 02/26/99
Alpharma, Inc. (NADA 65-470)Bacitracin Methylene Disalicylate soluble (BMD® soluble)Replacement chickens. An aid in the prevention and control of necrotic enteritis.ORAL: For making a medicated drinking water containing the equivalent of 100 mg of bacitracin per gallon to be used in the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to BMD®. Medicated drinking water containing the equivalent of 200 to 400 mg of bacitracin per gallon is used in the control of necrotic enteritis caused by C. perfringens susceptible to BMD®. Federal Register: 03/17/99
Roche Vitamins, Inc. (NADA 96-298)Lasalocid (Bovatec® )Rabbits. For the prevention of coccidiosis.MEDICATED FEED: Use of a lower concentration of lasalocid Type A medicated article (15 percent and 20 percent) to make a Type C rabbit feed. Also provided is a tolerance for drug residues in rabbits. Federal Register: 03/17/99
Pharmacia & Upjohn Co. (NADA 34-025)Lincomycin (Lincocin®)Dogs, cats, swine.SUBCUTANEOUS: Injectable use in dogs, cats, and swine. A swine residue tolerance and an ADI added. Federal Register: 03/18/99
Pharmacia & Upjohn Co. (NADA 97-505)Lincomycin (Lincomix®)Swine and Broiler ChickensMEDICATED FEED: Use of Lincomix® 20/50 Type A medicated article and Lincomix® 10 Type B medicated feed. Also add a zero withdrawal period, a swine residue tolerance, and an ADI. Federal Register: 03/18/99
Pharmacia & Upjohn Co. (NADA 111-636)Lincomycin (Lincomix®) soluble powderSwine and Broiler ChickensORAL: Use of Lincomix soluble powder in the drinking water of swine and broiler chickens. Also for a zero withdrawal period, establishing residue tolerances of 0.6 parts per million in swine liver and 0.1 ppm in swine muscle, and establishing an ADI of 25 micrograms per kilo of body weight per day. Federal Register: 03/18/99
Schering-Plough Animal Health Corp. (NADA 141-070)Propofol (Rapinovet Anesthetic Injection) RxCats. For general anesthesia.INTRAVENOUS: Expands the use to include cats; it is approved for dogs. Federal Register: 03/19/99
Pfizer, Inc. (NADA 141-061)Doramectin (Dectomax®)Cattle. Treat and control of infections and to protect from reinfections with nematodes including Haemonchus placei for 14 days after treatment.SUBCUTANEOUS AND INTRAMUSCULAR: To provide for persistent use and protect from reinfection with H. placei for 14 days after treatment. The approved use in cattle is for treatment and control of various gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites, and persistent use for certain worms. Federal Register: 03/19/99
Elanco Animal Health, A Division of Eli Lilly & Co. (NADA 141-064)Tilmicosin (Pulmotil®) Rx VFDSwine. For control of swine respiratory disease.MEDICATED FEED: For veterinary prescription use of tilmicosin Type C medicated swine feeds under a veterinary feed directive(VFD) provides a revised limitation to prevent accidental access by horses. Also provides a swine muscle tolerance and an acceptable daily intake(ADI). The limitation states "Do not allow horses or other equine access to feeds containing tilmicosin." Federal Register: 03/22/99
Pfizer, Inc. (NADA 15-102)Sulfadimethoxine tablets and boluses (SDM) RxDogs and cats. To treat bacterial infections.ORAL: The supplement supports prior approval, several sponsor changes, and requests codification. Federal Register: 04/01/99