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U.S. Department of Health and Human Services

Animal & Veterinary

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New Animal Drug Approvals - March/April 2003

FDA Veterinarian Newsletter March/April 2003 Volume XVIII, No 2

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Schering-Plough Animal Health Corp.
(NADA 141-206)
Florfenicol (Nuflor®)
Swine. For treatment of respiratory disease.
ORAL—The NADA provides for use of a florfenicol concentrate solution to make medicated drinking water for administration to swine for the treatment of respiratory disease associated with several bacterial pathogens. Tolerances for residues of florfenicol in swine liver at 2.5 ppm and 0.2 ppm in muscle are added to the regulation.
Federal Register 12/24/02

Bayer Corp., Agriculture Division, Animal Health
(NADA 141-208)
Imidacloprid, Ivermectin (Advantage® DUO) RX
Dogs. For the prevention of heartworm disease and treatment of flea infestations (Ctenocephalides felis).
TOPICAL—The NADA provides for veterinary prescription use in dogs of an imidacloprid and ivermectin topical solution for the prevention of heartworm disease caused by Dirofilaria immitis and treatment of flea infestations (Ctenocephalides felis).
Federal Register 12/26/02

Pfizer, Inc.
(NADA 141-207)
Danofloxacin mesylate (A180®) RX
Cattle. For treatment of bovine respiratory disease
SUBCUTANEOUS—The NADA provides for veterinary prescription use in cattle for treatment of bovine respiratory disease associated with Mannheimia (Pasteurella) haemolytica and Pasteurella multocida. FDA is also amending the regulation to add the acceptable daily intake(ADI) of 2.4 micrograms per kilogram of body weight per day and a tolerance in edible tissues of cattle at 0.2 ppm (parts per million) in liver and 0.2 ppm in muscle.
Federal Register 12/27/02

RMS Laboratories, Inc.
(NADA 141-210)
Triamcinolone (GenesisTM Topical Spray) RX
Dogs. For control of pruritus.
TOPICAL—The NADA provides for use of triamcinolone topical spray in dogs for the control of pruritus associated with allergic dermatitis.
Federal Register 01/31/03