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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for July and August 2004

FDA Veterinarian Newsletter September/October 2004 Volume XIX, No V

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

  • SIMPLICEF Tablets (Cefpodoxime proxetil) filed by Pharmacia and Upjohn Co., a division of Pfizer, Inc. (NADA 141-232). The product is for veterinary prescription use in dogs for treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, S. aureus, Streptococcus canis (group G, -hemolytic), -Escherichia coli, Pasteurella multocida, and Proteus mirabilis. Notice of approval was published August 30, 2004.
  • MECADOX and TERRAMYCIN (Carbadox and Oxytetracycline) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for swine, filed by -Phibro Animal Health (NADA 141-211). The Type C medicated feeds are for use in swine for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline, for treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency. Notice of approval was published August 18, 2004.
  • OPTAFLEXX, MGA, and RUMENSIN (Ractopamine hydrochloride, Melengestrol acetate, and Monensin sodium) for Type A medicated articles, filed by Elanco Animal Health (NADA 141-234). The NADA provides for the Type A medicated articles to make three-way combination Type C medicated feeds to be used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Notice of approval was published August 18, 2004.
  • OPTAFLEXX, MGA, RUMENSIN, and TYLAN (Ractopamine hydrochloride, Melengestrol acetate, Monensin sodium, and Tylosin phosphate) filed by Elanco Animal Health for Type A medicated articles (NADA 141-233). The NADA provides for the Type A medicated articles to make four-way combination Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; for prevention of coccidiosis due to E. bovis and E. zuernii; for suppression of estrus (heat); and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Notice of approval was published August 18, 2004.
  • PREVICOX (Firocoxib) filed by Merial Ltd. (NADA 141-230). The NADA provides for the veterinary prescription use of Firocoxib chewable tablets in dogs for the control of pain and inflammation associated with osteoarthritis. Notice of approval was published August 18, 2004.
  • SEDIVET1% Injection (Romifidine hydrochloride) filed by Boehringer Ingelheim Vetmedica, Inc. (NADA 141-229). The NADA provides for the veterinary prescription use of romifidine hydrochloride injectable solution in adult horses as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures, and as a pre-anesthetic to the induction of general anesthesia in adult horses. Notice of approval was published August 5, 2004.
  • EXCEDE for Swine Sterile Suspension (Ceftiofur crystalline free acid) filed by Pharmacia & Upjohn Co., a division of Pfizer, Inc., (NADA 141-235). The NADA provides for the veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. Notice of approval was published July 23, 2004.
  • SURPASS Topical Cream (1% Diclofenac sodium) filed by IDEXX Pharmaceuticals, Inc. (NADA 141-186). The product is for topical use in horses for the control of pain and inflammation associated with osteoarthritis in tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock, knee, fetlock, and pastern) joints. Notice of approval was published July 7, 2004.
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