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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVALS - September/October 1999

FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

CompanyGeneric and Brand Names Indications Routes/Remarks
Pfizer, Inc.
(NADA 141-111)
Carprofen (Rimadyl®) RxDogs. For the relief of pain and inflammation associated with osteoarthritis.ORAL: The chewable tablets are scored so that a half-tablet may be easily given. Amount to be administered is 1 milligram per pound of body weight twice daily. Tablets contain either 25, 75, or 100 milligrams of carprofen. This approval qualifies for three years of marketing exclusivity. Federal Register: 06/16/99
Schering-Plough Animal Health Corp.
(NADA 140-951)
Diclazuril (Clinacox™)Broiler chickens. For the prevention of coccidiosis in broiler chickens.MEDICATED FEED: The NADA provides for use of a Type A medicated article containing diclazuril for use in manufacturing a Type C medicated feed. Such feed indicated for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. A tolerance for diclazuril is established as is an ADI. Federal Register: 07/02/99
Pfizer, Inc.
(NADA 141-152)
Selamectin (Revolution™) RxDogs and Cats. For use as a topical parasiticide.TOPICAL: Selamectin kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations, prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite infestations in dogs and cats; in dogs for treatment and control of sarcoptic mange and in cats for treatment of intestinal hookworm and roundworm infections. The approval qualifies for 5 years of marketing exclusivity. Federal Register: 07/12/99
Pfizer, Inc.
(NADA 141-151)
Marbofloxacin (Zeniquin™) RxDogs. For treatment of infections associated with bacteria susceptible to marbofloxacin.ORAL: The drug is limited to veterinary prescription use and prohibited from extra-label use in food-producing animals. This approval qualifies for 5 years marketing exclusivity. Federal Register: 07/23/99