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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for September and October 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No V

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

  • ETOGESIC (etodolac) Injectable (NADA 141-274), filed by Fort Dodge Animal Health, Fort Dodge, IA. The approved NADA provides for the veterinary prescription use of ETOGESIC (etodolac) Injectable in dogs for the control of pain and inflammation associated with osteoarthritis. Notice of approval was published September 7, 2007.
  • COMFORTIS (spinosad) (NADA 141-277), filed by Elanco & Co., Indianapolis, IN. The approved NADA provides for the veterinary prescription use of COMFORTIS (spinosad) Chewable Tablets to kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides Felis) on dogs for one month. Notice of approval was published October 25, 2007.

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

  • DEXDOMITOR (dexmedetomidine hydrochloride) (NADA 141-267), filed by Orion Corporation, Espoo, Finland. The supplemental NADA provides for the veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative and analgesic to facilitate clinical examinations and procedures, and minor dental procedures in cats. Notice of approval was published September 7, 2007.
  • DRAXXIN (tulathromycin) Injectable Solution (NADA 141-244), filed by Pfizer, Inc., New York, NY. The supplemental NADA provides for the addition of a pathogen—Mycoplasma bovis—to the indication for use of tulathromycin solution in cattle, by subcutaneous injection, for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease. Notice of approval was published September 26, 2007.
  • ADEQUAN i.m. (polysulfated glycosaminoglycan) (NADA 140-901), filed by Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY. The supplemental NADA provides for the use of ADEQUAN i.m. (polysulfated glycosaminoglycan), an injectable solution, in horses and dogs by veterinary prescription for noninfectious degenerative and/or traumatic joint disease. The supplemental NADA provides for a revised food safety warning for use in horses. Notice of approval was published October 5, 2007.
  • OPTAFLEXX (ractopamine hydrochloride), MGA (melengesterol acetate), RUMENSIN (monensin), and TYLAN (tylosin phosphate) (NADA 141-233), filed by Elanco Animal Health, a division of Eli Lilly & Co., Indianapolis, IN. The supplemental NADA provides for the use of these Type A medicated articles to make dry and liquid four-way combination 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; for suppression of estrus (heat); and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. The supplemental NADA provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter, a revision to bacterial pathogen nomenclature, and an increase in the cattle liver tolerance. Notice of approval was published October 5, 2007.
  • EQUIPHEN (phenylbutazone) Paste (NADA 140-958), filed by Luitpold Pharmaceuticals, Inc., Shirley, NY. The supplemental NADA provides for the use of EQUIPHEN (phenylbutazone) Paste in horses for relief of inflammatory conditions associated with the musculoskeletal system. The supplemental NADA also provides for a revised human food safety warning on product labeling. Notice of approval was published October 25, 2007.

CVM has published in the Federal Register notice of the approval of this Conditional Approval (CA)

  • AQUAFLOR-CA1 (florfenicol) (CA 141-259), filed by Schering-Plough Animal Health Corp., Summit, NJ. The conditional approval provides for the use of AQUAFLOR-CA1 (florfenicol), a Type A medicated article, by veterinary feed directive to formulate Type C medicated feed for the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare. The drug is conditionally approved as of April 13, 2007; the effect of the final rule was delayed until October 9, 2007, pending establishment of 21 CFR Part 516.