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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for February 2008

FDA Veterinarian Newsletter January / February 2008 Volume XXIII, No I

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

  • ZILMAX (zilpaterol hydrochloride), RUMENSIN (monensin), and TYLAN (tylosine phosphate) Type A medicated articles (NADA 141-276), filed by Intervet, Inc., Millsboro, DE. The NADA provides for the use of ZILMAX (zilpaterol hydrochloride), RUMENSIN (monensin), and TYLAN (tylosine phosphate) Type A medicated articles to make dry and liquid three-way combination Type B and Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; also 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 Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. Notice of approval was published February 1, 2008.

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

  • REGUMATE (altrenogest) (NADA 131-310), filed by Intervet, Inc., Millsboro, DE. The supple-mental NADA provides for a revised warning statement on the product labeling of REGUMATE (altrenogest), an oral solution administered to mares for suppression of estrus. Notice of approval published February 21, 2008.
  • Phenylbutazone Tablets (NADA 91-818 and NADA 94-170), filed by IVX Animal Health, Inc., St. Joseph, MO. The supplemental NADAs provide for revisions to the warning state-ments on the product labeling for the use of Phenylbutazone Tablets in horses and dogs. Notice of approval published February 13, 2008.
  • DRAXXIN (tulathromycin) Injectable Solution (NADA 141-244), filed by Pfizer, Inc., New York, NY. The supplemental NADA provides for treatment of infectious bovine kerato-conjunctivitis associated with Moraxella bovis and the addition of a pathogen, My-coplasma hyopneumoniae, to the indication for use for treatment of swine respiratory disease. Notice of approval published February 1, 2008.

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

  • PHOENECTIN (ivermectin) Liquid for Horses (ANADA 200-202), filed by IVX Animal Health, Inc., St. Joseph, MO. The supplemental ANADA provides for the addition of indica-tions for use and minor revisions to the product labeling on ivermectin that conform to the pioneer product labeling. Notice of approval published February 21, 2008.

Correction

The previous edition of FDA Veterinarian listed an approval for AVIAX II, but the listing incorrectly included the name SIMPLICEF. Here is the correct listing.

  • AVIAX II (semduramicin) (NADA 141-281), filed by Phibro Animal Health, Ridgefield Park, NJ. The NADA provides for the use of AVIAX II (semduramicin) Type A medicated article containing semduramicin (as semduramicin sodium biomass) to manufacture Type C medicated broiler chicken feed for the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis. Notice of ap-proval was published January 4, 2008.