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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for September and October 2004

FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 6

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

EQUIMAX Paste (ivermectin 1.87% and praziquantel 14.03% oral paste) filed by Virbac AH, Inc. (NADA 141-215). The supplemental NADA provides for use in breeding, pregnant or lactating mares without adverse effects on fertility. The product is indicated for the use in horses for the treatment and control of various species of the following internal parasites: Tapeworms: Anoplocephala perfoliata; Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equines, Triodontophorus spp.; Small Strongyles including those resistant to some benzimidazole class compounds (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.; Pinworms (adults and fourth-stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults); Trichostrongylus axe; 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; and Dermatitis caused by Neck threadworm microfilariae, Onchocerca sp. Notice of approval was published September 3, 2004.

BANAMINE (flunixin meglumine) Injectable Solution filed by Schering-Plough Animal Health Corp. (NADA 101-479). The supplemental NADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia. It also provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection for control of pyrexia associated with acute bovine mastitis and for the establishment of a tolerance for residues of flunixin in milk. Notice of approval was published October 8, 2004.

EQVALAN (ivermectin 1.87 percent) Paste for Horses filed by Merial Ltd. (NADA 134-314). The supplemental NADA provides for revisions to the labeled indications for ivermectin oral paste used in horses. Specifically, under the sub-heading “Small Strongyles,” the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. Notice of approval was published October 4, 2004.

EQVALAN (ivermectin) Oral Liquid for Horses filed by Merial Ltd (NADA 140-439). The supplemental NADA provides for revisions to the labeled indications. Specifically, the supplement provides for the use of ivermectin oral liquid for the treatment and control of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus spp., including Coronocyclus coronatus and Coronocyclus labratus. The label descriptions of some currently approved parasite genera are also being revised to add included species for which data already exists in the NADA file and to reflect changes in scientific nomenclature. In addition, under the sub-heading “Small Strongyles,” the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. Notice of approval was published September 24, 2004.

IVOMEC (ivermectin) Injection for Cattle and Swine filed by Merial Ltd. (NADA 128-409). The supplemental application provides for an increased period of protection from reinfection with three species of internal parasites of cattle following administration of ivermectin solution by subcutaneous injection. Specifically, the period of persistent effectiveness is increased from 14 days to 28 days for Oesophagostomum radiatum, and from 14 days to 21 days for Trichostrongylus axei and Cooperia punctata. A veal calf warning statement is being added because residue depletion data for this class of cattle has not been submitted to the application. Notice of approval was published September 2, 2004.

CVM has published in the Federal Register notice of the approval of this Abbreviated New Animal Drug Application (ANADA)

NOROMECTIN (ivermectin) Pour On for Cattle filed by Norbrook Laboratories, Ltd. (ANADA 200-272). The application provides for topical use of 0.5 percent ivermectin solution on cattle for the treatment and control of various species of gastrointestinal roundworms (including Ostertagia ostertagi), lungworms, grubs, horn flies, sucking and biting lice, and sarcoptic mange mites. Norbrook Laboratories, Ltd.’s -NOROMECTIN Pour-On for Cattle is approved as a generic copy of Merial Ltd.’s -IVOMEC Pour-On for Cattle, approved under NADA 140-841. Notice of approval was published October 25, 2004.

CVM has published in the Federal Register notice of the approval of these Supplemental Abbreviated New Animal Drug Apppplications (ANADA)

PRAZI-C (praziquantel) Tablets filed by Phoenix Scientific, Inc. (ANADA 200-265). The supplement provides for OTC marketing of the tablets in 5-, 10-, and 50-tablet container sizes for use in the removal of the tapeworms (Dipylidium caninum and Taenia pisiformis) from dogs and puppies. The OTC pioneer product is marketed in 5-tablet container sizes only. The prescription praziquantel product includes additional labeling claims for use by or on the order of a licensed veterinarian, for removal of the canine cestode Echinococcus granulosus, and for removal and control of the canine cestode Echinococcus multilocularis. The Phoenix Scientific, Inc.’s PRAZI-C Tablets are approved as a generic copy of Bayer HealthCare LLC’s Tape Worm Tabs approved under NADA 111-798. Notice of approval was published October 25, 2004.

Oxytetracycline HCl Soluble Powder-343 filed by Phoenix Scientific, Inc. (ANADA 200-247). The supplement provides for the use of product for skeletal marking of finfish fry and fingerlings by immersion. The approval of this supplemental ANADA relied on publicly available safety and effectiveness data contained in Public Master File (PMF) 5667, which were compiled under National Research Support Project 7 (NRSP-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 October 22, 2004.

Flunixin Meglumine Injectable Solution filed by Agri Laboratories, Ltd. (ANADA 200-061). The supplement provides for the addition of a claim for veterinary prescription use by intravenous administration for control of fever and inflammation in beef cattle and nonlactating dairy cattle. The Agri Laboratories product is approved as a generic copy of Schering-Plough Animal Health Corp.’s BANAMINE Injectable Solution approved under NADA 111-798. Notice of approval was published September 2, 2004.