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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for New Animal Drugs for May and June 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No II

CVM has published in the Federal Register notice of the approval of these Supplemental New Animal Drug Applications (NADA)

  • TRIBRISSEN (trimethoprim and sulfadiazine) 400 Paste (NADA 131-918), filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine oral paste administered orally to horses as a systemic antibacterial. The product is used for the control of bacterial infections during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections, and abscesses. The revised labeling adds post-approval experience information, revises the warning statement, and updates the label format. The following post-approval experience was added to the label: “Horses have developed diarrhea during TRIBISSEN 400 Oral Paste treatment, which could be fatal. If fecal consistency changes during TRIBRISSEN 400 Oral Paste therapy, discontinue treatment immediately and contact your veterinarian.” Warnings are provided on the product label as follows: “Keep out of reach of children. Do not use in horses intended for human consumption.” Notice of approval was published May 31, 2006.
  • TRIBRISSEN (trimethoprim and sulfadiazine) 48% Injection (NADA 106-965), filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine injectable suspension administered to horses as a systemic antibacterial. The product is used for the control of bacterial infections during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections, and abscesses. The revised labeling adds post-approval experience information, revises the warning statement, and updates the label format. The following post-approval experience was added to the label: “Horses have developed diarrhea during TRIBISSEN 400 Oral Paste treatment, which could be fatal. If fecal consistency changes during TRIBRISSEN 400 Oral Paste therapy, discontinue treatment immediately and contact your veterinarian.” Warnings are provided on the product label as follows: “Keep out of reach of children. Do not use in horses intended for human consumption.” Notice of approval was published May 31, 2006.

CVM has published in the Federal Register notice of the approval of these Abbreviated NADAs (ANADA)

  • HEIFERMAX 500 (melengestrol acetate) Liquid Premix, OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin sodium), and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles to make dry and liquid, four-way combination drug Type C medicated feeds (ANADA 200-424), filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, ractopamine, monensin, and tylosin to make four-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200-424 is approved as a generic copy of Elanco Animal Health’s NADA 141-233 for combination feed use of MGA (melengestrol acetate), OPTAFLEXX, RUMENSIN, and TYLAN. Notice of approval was published June 1, 2006.
  • HEIFERMAX 500 (melengestrol acetate) Liquid Premix and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles to make two-way combination Type C medicated feeds (ANADA 200-427), filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and tylosin to make two-way combination Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200-427 is approved as a generic copy of Pharmacia and Upjohn Co.’s new animal drug application NADA 139-192 for combination use of MGA 500 (melengestrol acetate) Liquid Premix and TYLAN in cattle feed. Notice of approval was published May 12, 2006.