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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for March - August 2009

FDA Veterinarian Newsletter 2008, Volume XXIII, No VI

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

  • AVIAX II (semduramicin sodium biomass) and STAFAC (virginiamycin) (NADA 141-289), filed by Phibro Animal Health. The single-ingredient Type A medicated articles are used to make two-way combination drug Type C medicated feeds for broiler chickens. The application provides for use of the drugs in Type C medicated feeds. Notice of the approval was published August 18, 2009.
  • AVATEC (lasalocid sodium) and 3-NITRO (roxarsone) (NADA 141-293), filed by Alpharma, Inc. The single-ingredient Type A medicated feed articles are used to make two-way combination drug Type C medicated feeds for use in growing turkeys. The application also removes an incorrect human food safety warning and revises an animal safety limitation for use of roxarsone in chicken and turkey feeds. Notice of the approval was published July 15, 2009.
  • VETORYL (trilostane) Capsules (NADA 141-291), filed by Dechra, Ltd. The application provides for veterinary prescription use of VETORYL Capsules in dogs for treatment of pituitary dependent hyperadrenocorticism and for treatment of hyperadrenocorticism due to adrenocortical tumor. Notice of the approval was published May 11, 2009.
  • FELIMAZOLE (methimazole) Coated Tablets (NADA 141-292), filed by Dechra, Ltd. The NADA provides for veterinary prescription use of FELMIAZOLE Coated Tablets in cats for the treatment of hyperthyroidism. Notice of the approval was published June 11, 2009. (See FDA Approves First Drug to Treat Hyperthyroidism in Cats on page 2.)
  • PALLADIA (toceranib phosphate) Tablets (NADA 141-295), filed by Pharmacia & Upjohn Co. The NADA provides for veterinary prescription use of PALLADIA Tablets in dogs for the treatment of Patnaik Grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement. Notice of the approval was published June 18, 2009. (See FDA Approves Drug to Treat Cancer in Dogs on page 3.)

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

  • CHLORMAX (chlortetracycline), filed by Alpharma, Inc. (supplement to NADA 046-699). The supplement provides for revised Blue Bird labeling for chlortetracycline Type A medicated articles used to formulate Type B and Type C medicated feeds in various classes of livestock and poultry. Notice of the approval was published June 12, 2009.
  • SEVOFLO (sevoflurane) (supplement to NADA 141-103), filed by Abbott Laboratories. SEVOFLO is used for induction and maintenance of general anesthesia in dogs. The supplement provides for a revised induction dose. Notice of the approval was published March 11, 2009.
  • TYLAN (tylosin) Injection (supplement to NADA 012-965), filed by Elanco Animal Health. TYLAN is an injectable solution used for the treatment of animal diseases associated with several bacterial pathogens. The supplement provides for changing a bovine pathogen name on product labeling. Notice of the approval was published March 19, 2009.
  • PANACUR (fenbendazole), filed by Intervet, Inc. (supplement to NADA 104-494). The supplement provides for a revised human food safety warning on product labeling. Notice of the approval was published April 17, 2009.
  • NEO-OXY 50/50, NEO-OXY 100/100, and NEO-OXY 100/100 MR (neomycin and oxytetracycline) (supplement to NADA 138-939), filed by Pennfield Oil Co. The supplement provides for revised labeling of these products to comply with effectiveness findings under the DESI (Drug Efficacy Study Implementation) program. The products are two-way, fixed-combination Type A medicated articles used to make two-way combination drug Type B and Type C medicated feeds containing oxytetracycline and neomycin sulfate, in a 1:1 ratio, for several production and therapeutic indications in chickens, turkeys, swine, cattle, and sheep. Notice of the approval was published August 13, 2009.
  • REVOLUTION (selamectin) (supplement to NADA 141-152), filed by Pfizer, Inc. The supplement increases the minimum age of treatment to 8 weeks (previously 6 weeks) for kittens treated with the topical selamectin solution. Notice of the approval was published April 30, 2009.
  • VETORYL (trilostane) Capsules (supplement to NADA 141-291), filed by Dechra, Ltd. The supplement provides for use of a 10-milligram capsule size. Notice of the approval was published June 26, 2009.

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

  • GB (gentomicin sulfate and betamethasone valerate) Topical Spray (ANADA 200-388), filed by American Pharmaceuticals and Cosmetics, Inc. The ANADA provides for veterinary prescription use of GB Topical Spray in dogs. The product is approved as a generic copy of Schering-Plough Animal Health Corporation’s GENTOCIN Topical Spray, under NADA 132-388. Notice of the ANADA approval was published May 15, 2009.
  • Amprolium 9.6% Oral Solution (ANADA 200-463), filed by IVX Animal Health, Inc. The ANADA provides for the use of generic amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis. The product is a generic copy of Huvepharma, AD’s AMPROVINE 9.6% Solution, approved under NADA 13-149. Notice of the ANADA approval was published March 11, 2009.
  • Ceftiofur Sodium Sterile Powder (ANADA 200-420), filed by Cephazone Pharma, LLC. The ANADA provides for the use of Ceftiofur Sodium Sterile Powder as an injectable solution in dogs, horses, cattle, swine, day-old chickens, turkey poults, sheep, and goats as therapy for various bacterial infections. The product is a generic copy of Pharmacia & Upjohn Co.’s NAXCEL (ceftiofur sodium) Sterile Powder for Injection, approved under NADA 140-338. Notice of the ANADA approval was published July 15, 2009.
  • Nitrofurazone Soluble Dressing (ANADA 200-425), filed by First Priority, Inc. The ANADA provides for use of Nitrofurazone Soluble Dressing in horses for prevention or treatment of superficial bacterial infections of wounds, burns, and cutaneous ulcers. The product is a generic copy of Squire Laboratories, Inc.’s FURA-ZONE (nitrofurazone) ointment, approved under NADA 132-427. Notice of the ANADA approval was published August 3, 2009.
  • Flunixin Injection –S (ANADA 200-476), filed by Norbrook Laboratories, Ltd. The ANADA provides for use of Flunixin Injection –S in swine for various bacterial infections. The product is a generic copy of Schering-Plough Animal Health’s BANAMINE-S (flunixin meglumine) Injectable Solution, approved under NADA 101-479. Notice of the ANADA approval was published July 15, 2009.