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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for October, November and December 2005, and January 2006

FDA Veterinarian Newsletter September/October 2005 Volume XX, No V

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

  • CYDECTIN (moxidectin) Oral Drench for Sheep (NADA 141-247), filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for the oral use of moxidectin solution for the treatment and control of the adult and larval (L4) stages of the following internal parasites of sheep: Haemonchus contortus, Teladorsagia circumcincta, Teladorsagia trifurcate, Trichostrongylus axei, Trichostrongylus colubriformis, Trichostrongylus vitrinus, Cooperia curticei, Cooperia oncophora, Oesophagostomum columbianum, Oesophagostomum venulosum, Nematodirus battus, Nematodirus filicolis, and Nematodirus spathiger. Notice of approval was published December 23, 2005.
  • AQUAFLOR (florfenicol) Type A medicated article (NADA 141-246), filed by Schering-Plough Animal Health Corporation. The NADA provides for the use of florfenicol Type A medicated article by veterinary feed directive to formulate Type C medicated feeds for the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri. Notice of approval was published November 21, 2005.

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

  • RUMENSIN 80 (monensin sodium) Type A medicated article (NADA 95-735), filed by Elanco Animal Health. The supplement provides for the use of RUMENSIN 80 Type A medicated article in Type C medicated feeds fed in component feeding systems (including top dress) used for increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows. Notice of approval was published January 11, 2006.
  • LEGEND Multi-dose (hyaluronate sodium) Injectable Solution (NADA 140-883), filed by Bayer HealthCare LLC, Animal Health Division. The supplemental NADA provides for veterinary prescription use of this hyaluronate sodium solution, formulated with a benzyl alcohol preservative, from a multi-dose vial for intravenous administration to horses for the treatment of carpal or fetlock osteoarthritis. Notice of approval was published January 11, 2006.
  • RUMENSIN 80 (monensin sodium) Type A medicated article (NADA 95-735), filed by Elanco Animal Health. The supplemental NADA revises the description of growing cattle fed monensin Type C medicated feeds for increased rate of weight gain and for prevention and control of coccidiosis. Notice of approval was published January 3, 2006.
  • MICOTIL 300 (tilmicosin phosphate)Injectable Solution (NADA 140-929), filed by Elanco Animal Health approved for the veterinary prescription use of an injectable solution of tilmicosin phosphate for respiratory disease in cattle and sheep. The supplemental NADA adds user safety information to product labeling related to the mechanism of toxicity and medical intervention. Notice of approval was published December 20, 2005.
  • QUEST (moxidectin 2.0%) Gel (NADA 141-087) and QUEST Plus (moxidectin 2.0%/praziquantel 12.5%) Gel (NADA 141-216), filed by Fort Dodge Animal Health, Division of Wyeth. Both products are used for the treatment and control of various species of internal parasites in horses and ponies. The supplemental NADAs provide for use of the products for the treatment and control of two additional species of adult small strongyles, which have been added to the product labeling: adult Cylicocyclus radiatus and Petrovinema poculatus. The products were already approved for treatment and control of the following parasites in horses and ponies: Large strongyles – Strongylus vulgaris (adult and L4/L5 arterial stages), Strongylus edentatus – (adult and tissue stages), Triodontophorus brevicauda (adults), Triodontophorus serratus (adults); Small strongyles (adults) –
    Cyathostomum catinatum, Cyathostomum pateratum, Cylicostephanus spp., including Cylicostephanus calicatus, Cylicostephanus goldi, Cylicostephanus longibursatus, Cylicostephanus minutus, Cylicocyclus spp., including Cylicocyclus insigne, Cylicocyclus leptostomum, Cylicocyclus nassatus, Coronocyclus spp., including Coronocyclus coronatus, Coronocyclus labiatus, Coronocyclus labratus, Gyalocephalus capitatus; Small strongyles – undifferentiated luminal larvae; Encysted cyathostomes – Late L3 and L4 mucosal cyathostome larvae; Ascarids – Parascaris equorum (adults and L4 larval states; Pinworms – Oxyuris equi (adults and L4 larval stages); Hairworms – Trichostrongylus axei (adults); Large-mouth stomach worms – Habronema muscae (adults); Horse stomach bots – Gasterophilus intestinalis (2nd and 3rd instars), Gasterophilus nasalis (3rd instars); Tapeworms – Anoplocephala perfoliata (adults). Notice of approval was published December 19, 2005.
  • ZIMECTERIN GOLD (ivermectin 1.55%/praziquantel 7.75%) Paste (NADA 141-214), filed by Merial, Ltd., is an over-the-counter product for oral use for the treatment and control of the following parasites in horses: Tapeworms – Anoplocephala perfoliata; Large strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus and Craterostomum acuticaudatum; Small strongyles (adults, including those resistant to some benzimidazole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. breviacapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small strongyles – fourth-stage larvae; Pinworms (adults and fourth-stage larvae) – Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae – Parascaris equorum; Hairworms (adults) – Trichostrongylus axei; Large-mouth stomach worms (adults) – Habronema muscae; Bots (oral and gastric stages) – Gasterophilus ssp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) – Dictyocalulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; and Dermatitis caused by neck threadworm microfilariae of Onchocerca sp. The supplemental NADA reduces the minimum age for administration from 5 months to 2 months of age. Notice of approval was published November 21, 2005.
  • TYLAN (tylosin tartrate) Soluble Powder (NADA 13-076), filed by Elanco Animal Health, for use in honey bees for the control of American foulbrood (Paenibacillus larvae). The approval of this supplemental NADA relied on publicly available safety and effectiveness data contained in Public Master File (PMF) 5783, which were compiled under National Research Support Project #7, a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for special uses. Notice of approval was published November 16, 2005.
  • EQUIMAX (ivermectin 1.87%/praziquantel 14.03%) Paste (NADA 141-215), filed by -Virbac AH, Inc. The supplemental NADA provides revised labeling for ivermectin and praziquantel oral paste used in horses for the treatment and control of various internal parasites. The amended product labeling separates parasite life stages in the indications section. The product is indicated for treatment and control of the following parasites: Tapeworms – Anoplocephala perfoliata; Large strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), Strongylus edentatus (also tissue stages), Strongylus equinus, Triodontophorus spp.; Small strongyles (adults, including those resistant to some benzimidazole class compounds) – Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.; Small strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage larvae) – Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) – Parascaris equorum; Hairworms (adults) – Trichostrongylus axei; Large-mouth Stomach Worms (adults) – Habronema muscae; Bots (oral and gastric stages) – Gasterophilus spp.; Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by Neck threadworm microfilariae – Onchocerca sp. Notice of approval was published November 1, 2005.

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

  • EQUIZONE 100 (phenylbutazone) Powder (ANADA 200-334), filed by A & G Pharmaceuticals, Inc. The ANADA provides for the veterinary prescription use of a phenylbutazone powder administered to horses in feed for the relief of inflammatory conditions associated with the musculoskeletal system. A & G Pharmaceuticals, Inc.’s, EQUIZONE 100 is approved as a generic copy of Phoenix Scientific, Inc.’s, Phenylbute (phenylbutazone) Tablets, USP, approved under NADA 91-818. Notice of approval was published January 6, 2006.
  • Furosemide (furosemide) Syrup 1% (ANADA 200-373), filed by First Priority, Inc. The ANADA provides for the oral use of furosemide syrup in dogs for the treatment of edema. First Priority, Inc.’s, FUROSEMIDE Syrup 1% is approved as a generic copy of Intervet, Inc.’s, LASIX (furosemide) Syrup 1%, approved under NADA 102-380. Notice of approval was published December 27, 2005.
  • PRICONAZOLE (miconazole nitrate) Lotion 1% and PRICONAZOLE (miconazole nitrate) Spray 1% (ANADA 200-362), filed by First Priority, Inc. The ANADA provides for topical use of miconazole nitrate on dogs and cats for the treatment of fungal infections caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes. First Priority’s PRICONAZOLE Lotion 1% and PRICONAZOLE Spray 1% are approved as generic copies of Schering-Plough Animal Health Corp.’s CONOFITE Lotion 1% and Spray 1%, approved under NADA 95-184. Notice of approval was published December 9, 2005.
  • SULFAMED-G (sulfadimethoxine) Soluble Powder (ANADA 200-376), filed by Cross Vetpharm Group Ltd. The ANADA provides for the oral use of sulfadimethoxine soluble powder to create a solution administered as a drench to cattle or in the drinking water of chickens, turkeys, or cattle for the treatment of coccidiosis or various bacterial diseases. For broiler and replacement chickens, the product is indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. For meat-producing turkeys, the product is indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. For dairy calves, dairy heifers, and beef cattle, the product is indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot. Cross Vetpharm Group Ltd.’s SULFAMED-G Soluble Powder is approved as a generic copy of Pfizer, Inc.’s ALBON (sulfadimethoxine) Soluble Powder, approved under NADA 46-285. Notice of approval was published December 9, 2005.
  • TETRAMED 324 HCA (tetracycline hydrochloride) Soluble Powder (ANADA 200-374), filed by Cross Vetpharm Group Ltd. The ANADA provides for the use of tetracycline hydrochloride soluble powder in the drinking water of calves, swine, chickens, and turkeys for the treatment and control of various bacterial infections. For swine and calves, the product is indicated for the control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., and Klebsiella spp. sensitive to tetracycline hydrochloride. For chickens, the product is indicated for the control of chronic respiratory disease and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli and infectious synovitis caused by Mycoplasma synoviae sensitive to tetracycline hydrochloride. For turkeys, the product is indicated for the control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms susceptible to tetracycline hydrochloride. Cross Vetpharm Group Ltd.’s TETRAMED 324 HCA is approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s TETRASURE 324 (tetracycline hydrochloride), approved under NADA 65-496. Notice of approval was published -November 7, 2005.
  • HEIFERMAX 500 Liquid Premix (melengestrol acetate), RUMENSIN (monensin sodium), and TYLAN (tylosin tartrate) Type A medicated articles (ANADA 200-375), filed by Ivy Laboratories. The ANADA provides for use of melengestrol acetate Type A medicated article with monensin and tylosin Type A medicated articles to make three-way combination Type C medicated feeds for heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, for suppression of estrus (heat), and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes. Ivy Laboratories’ ANADA 200-375 is approved as a generic copy of Pharmacia & Upjohn’s NADA 138-870. Notice of approval was published November 2, 2005.