• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

Abbreviated New Animal Drug Approvals - September/October 2003

FDA Veterinarian Newsletter September/October 2003 Volume XVIII, No 5

Company
Generic and (Brand) Names
Indications
Routes/Remarks

West-Ward Pharmaceutical Corp.
(ANADA 200-323)
Phenylbutazone RX
Horses. For relief of inflammatory conditions associated with the musculoskeletal system.
ORAL—The ANADA provides for oral use of phenylbutazone tablets in horses. West-Ward’s tablets are a generic copy of Boehringer Ingelheim Vetmedica’s BIZOLIN approved under NADA 99-618.
Federal Register 07/10/03

Pennfield Oil Co.
(ANADA 200-355)
Salinomycin, Chlortetracycline, Roxarsone
Broiler Chickens.
MEDICATED FEED—The ANADA provides for the use of single-ingredient Type A medicated articles containing salinomycin, chlortetracycline, and roxarsone to make three-way combination drug Type C medicated feeds. Pennfield Oil Co.’s ANADA 200-355 is a generic copy of Alpharma, Inc.’s NADA 140-867.
Federal Register 07/10/03

Phoenix Scientific, Inc.
(ANADA 200-287)
Gentamicin Sulfate, Betamethasone valerate, Clotrimazole
(GBC ointment™) RX
Dogs. For the treatment of otitis externa.
OPTHALMIC AND TOPICAL—The ANADA provides for use of gentamicin sulfate, betamethasone valerate, and clotrimazole ointment for the treatment of canine otitis externa associated with yeast and/or bacteria susceptible to gentamicin. GBC ointment is a generic copy of Schering-Plough Animal Health’s Otomax approved under NADA 140-896.
Federal Register 07/21/03

Bioniche Animal Health USA, Inc.
(ANADA 200-266)
Phenylbutazone
(Butequine) RX
Horses. For relief of inflammatory conditions.
ORAL—The ANADA provides for the oral use of Butequine paste in horses for the relief of inflammatory conditions associated with the musculoskeletal system. Butequine is a generic copy of Schering-Plough Animal Health’s Phenylzone Paste approved under NADA 116-087.
Federal Register 07/25/03