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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for March - July 2008

FDA Veterinarian Newsletter March / April 2008 Volume XXIII, No II

CVM has published in the Federal Register notice of the approval of these

New Animal Drug Applications (NADAs)

  • PANACUR PLUS (ivermectin, fenbendazole, and praziquantel) Soft Chews (NADA 141-286), filed by Intervet, Inc., Millsboro, DE. The approved NADA provides for the veterinary prescription use of PANACUR PLUS (ivermectin, fenbendazole, and praziquantel) Soft Chews for the treatment and control of various internal parasites and for the treatment of canine heartworm disease in adult dogs. Notice of approval was published June 13, 2008.
  • CONVENIA (cefovecin sodium) Injectable (NADA 141-285), filed by Pfizer, Inc., New York, NY. The approved NADA provides for the veterinary prescription use of CONVENIA (cefovecin sodium) Injectable in cats and dogs by subcutaneous injection for the treatment of skin infections. Notice of approval was published May 22, 2008.
  • NUFLOR GOLD (florfenicol) Injectable Solution (NADA 141-265), filed by Schering-Plough Animal Health Corp., Summit, NJ. The approved NADA provides for the use of NUFLOR GOLD (florfenicol) Injectable Solution by subcutaneous injection in beef and non-lactating dairy cattle for the treatment of bovine respiratory disease. Notice of approval was published April 18, 2008.
  • ZILMAX (zilpaterol hydrochloride) RUMENSIN (monensin USP), TYLAN (tylosin phosphate), and MGA (melengestrol acetate) Type A medicated articles (NADA 141-280), filed by Intervet, Inc., Millsboro, DE. The approved NADA provides for the use of ZILMAX (zilpaterol hydrochloride), RUMENSIN (monensin USP), TYLAN (tylosin phosphate), and MGA (melengestrol acetate) Type A medicated articles to make dry and liquid four-way combination Type B and Type C medicated feeds 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 reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacte-rium (Actinomyces) pyogenes; and suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 20 to 40 days on feed. Notice of approval was published April 8, 2008.
  • ZILMAX (zilpaterol hydrochloride) and MGA (melengestrol acetate) Type A medicated articles (NADA 141-284), filed by Intervet, Inc., Millsboro, DE. The approved NADA provides for the use of ZILMAX (zilpaterol hydrochloride) and MGA (melengestrol ace-tate) Type A medicated articles to make dry and liquid two-way combination Type B and Type C medicated feeds used for in-creased rate of weight gain, improved feed efficiency, and increased carcass leanness; and for suppression of estrus (heat) in heifers in confinement for slaughter during the last 20 to 40 days on feed. Notice of approval was published March 31, 2008.
  • BMD (bacitracin methylene disalicylate) and NICARB (nicarbain) Type A medicated articles (NADA 141-279), filed by Alpharma, Inc., Bridgewater, NJ. The approved NADA provides for the use of BMD (bacitracin methylene disalicylate) and NICARB (nicar-bazin) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for broiler chickens. Notice of approval was published March 26, 2008.
  • ZILMAX (zilpaterol hydrochloride) and RUMENSIN (monensin USP) Type A medicated articles (NADA 141-278), filed by Intervet, Inc., Millsboro, DE. The approved NADA provides for the use of ZILMAX (zilpaterol hydrochloride) and RUMENSIN (monensin USP) Type A medicated articles to make dry and liquid, two-way combination Type B and Type C medicated feeds for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. Notice of approval was published March 18, 2008.
    CVM has published in the Federal Register notice of the approval of these

CVM has published in the Federal Register notice of the approval of these

Supplemental New New Animal Drug Applications (NADAs)

  • VETISULID (sulfachlorpyridazine sodium) Powder (NADA 33-373), filed by Fort Dodge Animal Health Corp., Fort Dodge, IA. The NADA is approved for the oral use of VETISULID (sulfachlorpyridazine sodium) Powder in calves and swine for the treatment of diarrhea caused or complicated by Escherichia coli (colibacillosis). The supplemental NADA provides for a revised food safety warning statement for oral use of sulfachlorpyridazine in the milk replacer of ruminating calves. Notice of approval was published June 24, 2008
  • TYLAN 40 SULFA-G (tylosin phosphate and sulfamethazine) Elliptical Pellets (NADA 041-275), filed by Elanco Animal Health, a Division of Eli Lilly & Co., Indianapolis, IN. The approved supplemental NADA provides for revision of an effectiveness claim and pathogen nomenclature on TYLAN 40 SULFA-G (tylosin phosphate and sulfamethazine) Elliptical Pellets, a Type A medicated ar-ticle. Notice of approval was published June 17, 2008.
  • DERAMAXX (deracoxib) Chewable Tablets, (NADA 141-203), filed by Novartis Animal Health US, Inc., Greensboro, NC. The ap-proved supplemental NADA provides for the addition of a 50-milligram size of DERAMAXX (deracoxib) Chewable Tablets used for the control of pain and inflammation in dogs. Notice of approval was published June 13, 2008.
  • PROHEART 6 (moxidectin) Sustained Release Injectable for Dogs (NADA 141-189), filed by Fort Dodge Animal Health, Division of Wyeth, Fort Dodge, IA. The approved original NADA provides for veterinary prescription use of PROHEART 6 (moxidectin) Sustained Release Injectable for Dogs, used for prevention of heartworm disease and treatment of existing hookworm infections. The approved supplemental NADA updates the warning, precaution, adverse reactions, and post-approval experience sections of the product labeling. Notice of approval was published June 9, 2008.
  • BAYTRIL 100 (enrofloxacin) injectable solution (NADA 141-068), filed by Bayer HealthCare LLC, Animal Health Division, Shawnee Mission, KS. The approved supplemental NADA provides for the use of BAYTRIL 100 (enrofloxacin) injectable solution in swine for the treatment and control of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. Notice of approval was published April 23, 2008.
  • VETSULIN (porcine insulin zinc) Suspension (NADA 141-236), filed by Intervet, Inc., Millsboro, DE. The approved supplemental NADA provides for the veterinary prescription use of VETSULIN (porcine insulin zinc) Suspension for the reduction of hypergly-cemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. The application also provides for a lower initial dosage of insulin for dogs. Notice of approval was published April 18, 2008.
  • BAYTRIL 100 (enrofloxacin) injectable solution (NADA 141-068), filed by HealthCare, LLC, Animal Health Division, Shawnee Mis-sion, KS. The approved NADA provides for the use of Baytril 100 (enrofloxacin) injectable solution for the treatment of bovine respiratory disease associated with several bacterial pathogens. The supplemental NADA provides for the use of the product in female dairy cattle less than 20 months of age. Notice of approval was published April 2, 2008.
  • PEN BP-48 (penicillin G benzathine and penicillin G procaine) injectable suspension (NADA 65-498), filed by IVX Animal Health, Inc., St. Joseph, MO. The approved NADA provides for the use of PEN BP-48 (penicillin G benzathine and penicillin G procaine) injectable suspension for the treatment of animal diseases associated with several bacterial pathogens. The supplemental NADA provides for changing a bovine pathogen name from Corynebacterium pyogenes to Actinomyces pyogenes on product labeling. Notice of approval was published March 31, 2008.
     
  • TETRADURE 300 (oxytetracycline) Injection (NADA 141-143), filed by Norbrook Laboratories, Ltd., Newry, Northern Ireland. TETRADUE 300 (oxytetracycline) Injection is approved for use to treat various bacterial diseases of cattle and swine. The sup-plemental NADA provides for changing a bovine pathogen genus from Haemophilus to Histophilus on product labeling. Notice of approval was published March 20, 2008.
  • PEN-G MAX (penicillin G procaine) Aqueous Suspension (NADA 65-110), filed by IVX Animal Health, Inc., St. Joseph, MO. PEN-G MAX (penicillin G procaine) Aqueous Suspension is used for the treatment of animal diseases associated with several bacterial pathogens. The supplemental NADA provides for changing the pathogen name from Erysipelothrix insidiosa to Erysipelothrix rhu-siopathiae on product labeling. Notice of approval was published March 17, 2008.
  • TOMORROW (cephapirin benzathine) Intramammary Infusion (NADA 108-114), filed by Fort Dodge Animal Health, Division of Wyeth, Fort Dodge, IA. The supplemental NADA revises labeling for TOMORROW (cephapirin bezathine) Intramammary Infusion administered to dairy cows entering their dry period for the treatment of mastitis. Notice of approval was published March 7, 2008.
  • VALBAZEN (albendazole) Oral Suspension (NADA 110-048), filed by Pfizer, Inc., New York, NY. The supplemental NADA provides for the use of VALBAZEN (albendazole) Oral Suspension for the treatment of liver flukes in nonlactating goats. The approval of this supplemental NADA relied on publicly available safety and effectiveness data contained in Public Master File 5582, which were compiled under National Research Support Project-7, a national agricultural research program for obtaining clearances for the use of new drugs in minor animal species and special uses. Notice of approval was published February 29, 2008.

CVM has published in the Federal Register notice of the approval of these

Abbreviated New New Animal Drug Applications (ANADAs)

  • BUTORPHIC (butorphanol tartrate) Injection (ANADA 200-332), filed by Lloyd, Inc., Shenandoah, IA. The ANADA provides for the veterinary prescription use of BUTORPHIC (butorphanol tartrate) Injection in horses for the relief of pain associated with colic and postpartum pain. Lloyd’s BUTORPHIC Injection is approved as a generic copy of TORBUGESIC, sponsored by Fort Dodge Ani-mal Health, Division of Wyeth, under NADA 135-780. Notice of approval was published June 2, 2008.
  • PETREM (sevoflurane) (ANADA 200-438), filed by Minrad, Inc., Buffalo, NY. The ANADA provides for the use of PETREM (se-voflurane) inhalant anesthetic in dogs. The product is approved as a generic copy of SEVOFLO, sponsored by Abbott Laborato-ries, under NADA 141-103. Notice of approval was published May 7, 2008.

CVM has published in the Federal Register notice of the approval of these

Supplemental Abbreviated New New Animal Drug Applications (ANADAs)

  • BIMECTIN (ivermectin) Paste 1.87% (ANADA 200-326), filed by Cross Vetpharm Group Ltd., Dublin, Ireland. The approved sup-plemental ANADA provides for the addition of effectiveness claims against various species of internal parasites of horses on the labeling of BIMECTIN (ivermectin) Paste 1.87%. Notice of approval was published June 17, 2008.
  • FLUNIXIN MEGLUMINE INJECTION (ANADA 200-124), filed by IVX Animal Health, Inc., St. Joseph, MO. The supplemental ANADA provides for veterinary prescription use of FLUNIXIN MEGLUMINE INJECTION intravenously in lactating dairy cattle for the control of pyrexia associated with acute bovine mastitis. Notice of approval was published May 15, 2008.