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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for February and March 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No I

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

  • ADVANTAGE MULTI™ (imidacloprid 10% and moxidectin 2.5%) (NADA 141-251) and ADVANTAGE MULTI™ (imidacloprid 10% and moxidectin 1%) (NADA 141-254), filed by Bayer HealthCare LLC, Animal Health Division. The first NADA provides for the veterinary prescription use of ADVANTAGE MULTI™ for dogs and is a topical solution used for the prevention of heartworm disease, the treatment of flea infestations, and the treatment and control of several internal parasites. The second NADA provides for the veterinary prescription use of ADVANTAGE MULTI for cats and is a topical solution used for the prevention of heartworm disease, the treatment of flea infestations, and the treatment and control of ear mites and several internal parasites. Notice of approval was published March 9, 2007.
  • CERENIA™ (maropitant citrate) Tablets (NADA 141-262), filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of maropitant citrate tablets in dogs for the prevention of acute vomiting and for the prevention of vomiting due to motion sickness. Also approved is Pfizer’s NADA 141-263 for CERENIA™ Injectable Solution, used by veterinary prescription in dogs for the prevention and treatment of acute vomiting. Notice of the approvals was published March 1, 2007.
  • RECONCILE® (fluoxetine hydrochloride) Chewable Tablets (NADA 141-272), filed by Elanco Animal Health, a division of Eli Lilly & Co. The NADA provides for the veterinary prescription use of RECONCILE® Chewable Tablets for the treatment of canine separation anxiety in conjunction with a behavior modification plan. Notice of approval was published February 12, 2007.
  • 35% PEROX-AID® (hydrogen peroxide) (NADA 141-255), filed by Eka Chemicals, Inc. The NADA provides for the use of 35% PEROX-AID® to control mortality in freshwater-reared finfish eggs due to saprolegniasis, to control mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum, and to control mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with Flavobacterium columnare (Flexibacter columnaris). Notice of approval was published February 6, 2007.

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

  • BAYTRIL® 100 (enrofloxacin) Injectable Solution (NADA 141-068), filed by Bayer Healthcare LLC, Animal Health Division. The product is approved for the treatment of bovine respiratory disease associated with several bacterial pathogens. The supplemental NADA provides for changing a pathogen name from Pasteurella haemolytica to Mannheimia haemolytica on product labeling. Notice of approval was published March 9, 2007.
  • SYNANTHIC® (oxfendazole) Bovine Dewormer Suspension 22.5% and SYNANTHIC® (oxfendazole) Bovine Dewormer Suspension 9.06% (NADA 140-854), filed by Fort Dodge Animal Health, Division of Wyeth. This supplemental NADA was approved for oral use over-the-counter of SYNANTHIC in cattle for the removal of various internal parasites. Notice of approval was published March 9, 2007.
  • PANACUR® (fenbendazole) Paste (NADA 120-648), and SAFE-GUARD® (fenbendazole) Paste (NADA 132-872), filed by Intervet, Inc. The first supplemental NADA provides for the use of PANACUR® (fenbendazole) Paste in horses for the control of various internal parasites, while the second one provides for the safe use of SAFE-GUARD® (-fenbendazole) Paste in cattle for the control of various internal parasites. The supplemental -NADAs provide for a revised human food safety warning on product labeling. Notice of the two approvals was published March 9, 2007.
  • ZILMAX® (zilpaterol hydrochloride 4.8%) (NADA 141-258), filed by Intervet, Inc. The supplemental NADA provides for the use of ZILMAX® (zilpaterol hydrochloride 4.8%) Type A medicated article to formulate Type B and Type C medicated cattle feeds. The supplemental NADA provides for the removal of a caution statement against the formulation of pelleted feeds from labeling. Notice of approval was published March 1, 2007.
  • COBAN® 60 and COBAN®90 (monensin, USP) (NADA 38-878), filed by Elanco Animal Health, a Division of Eli Lilly & Co. The supplemental NADA provides for use of COBAN® 60 and COBAN® 90 (monensin, USP) Type A medicated articles in the feed of chickens. The supplement provides for minor revisions to labeling. Notice of approval was published March 1, 2007.
  • REVALOR-XS (trenbolone acetate and estradiol) (NADA 141-269), filed by Intervet, Inc. The supplemental NADA provides for the use of REVALOR-XS (trenbolone acetate and estradiol), an ear implant, for increased rate of weight gain and improved feed efficiency in steers fed in confinement for slaughter. The product was assigned over-the-counter status by FDA. The approval qualifies for 3 years of marketing exclusivity beginning on the date of approval; notice of approval was published February 15, 2007.
  • BOVATEC 91 (lasalocid) Type A medicated article (NADA 138-993), filed by ADM Alliance Nutrition, Inc., Quincy, IL. The supplemental NADA provides for the use of lasalocid to make MooMan’s® Cattle Mineral BT, a free-choice mineral Type C medicated feed for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). The supplement provides for the use of a lasalocid Type A medicated article containing a 20-percent lasalocid activity per pound. Notice of approval was published February 2, 2007.

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

  • HEIFERMAX® 500 (melengestrol acetate) Liquid Premix, OPTAFLEXX® (ractopamine hydrochloride), and RUMENSIN® (monensin sodium) single-ingredient Type A medicated article (ANADA 200-448), filed by Ivy Laboratories. The ANADA provides for the use of these products to make dry and liquid, three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. The ANADA is approved as a generic copy of Elanco Animal Health’s NADA 141-234 for combination feed use of MGA® 500, OPTAFLEXX®, and RUMENSIN®. Notice of approval was published March 8, 2007.
  • GENTAMICIN SULFATE TOPICAL SPRAY (gentamicin sulfate, USP, with betamethasone valerate, USP) (ANADA 200-415), filed by First Priority, Inc. The ANADA provides for the use of gentamicin sulfate with betamethasone valerate on dogs for the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin. First Priority’s Gentamicin Sulfate Topical Spray is approved as a generic copy of Schering-Plough Animal Health Coprporation’s GENTOCIN® Topical Spray, approved under NADA 132-338. Notice of approval was published February 6, 2007.

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

  • COMPONENT® TE-200 with TYLAN® (trenbolone acetate and estradiol with tylosin tartrate) (ANADA 200-346), filed by Ivy Laboratories, a Division of Ivy Animal Health, Inc. The product is a subcutaneous implant used for increased rate of weight gain and improved efficiency in steers and heifers fed in confinement for slaughter. The supplemental ANADA provides for the addition of a pellet containing 29 milligrams tylosin tartrate to the approved COMPONENT® TE-200 implant. Notice of approval was published March 1, 2007.
  • NOROMECTIN® (Ivermectin) Pour-On (ANADA 200-272), filed by Norbrook Laboratories, Ltd. The supplemental ANADA adds claims for persistent effectiveness of Noromectin Pour-On for Cattle to control infections and protect against re-infection with the following internal and external parasites: Oesophagostomum radiatum and Dictyocaulus viviparus for 28 days after treatment; Cooperia punctata and Trichostrongylus axeia for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora, and Cooperia surnabada for 14 days after treatment; and Damalina bovis for 56 days after treatment. The effect of the supplement is to add claims that are no longer protected by 3 years of marketing exclusivity that expired on November 24, 2006. Notice of approval was published February 12, 2007.