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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for November 2008 - March 2009

FDA Veterinarian Newsletter 2008 Volume XXIII, No V

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

  • TOPMAX 9 (ractopamine hydrochloride) Type A medicated article (NADA 141-290), filed by Elanco Animal Health, A Division of Eli Lilly & Co., Indianapolis, IN. The Type A medicated article is used to make Type B and Type C medicated feeds used for increased rate of weight gain and improved feed efficiency in finishing turkeys. Notice of approval was published December 1, 2008.

 

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

  • OPTAFLEXX (ractopamine hydrochloride), HEIFERMAX 500 (melengestrol acetate), and RUMENSIN (monensin), and TYLAN (tylosin phosphate) Type A medicated articles (supplement to ANADA 200-424), filed by Ivy Laboratories, Division of Ivy Animal Health, Inc., Overland Park, KS. 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; and a revision to bacterial pathogen nomenclature. Notice of the approval was published December 11, 2008.
  • TYLAN (tylosin phosphate) Type A medicated article (supplement to NADA 012 491), filed Elanco Animal Health, A Division of Eli Lilly & Co., Indianapolis, IN. The supplement provides for use of tylosin tartrate in medicated drinking water for swine for 3 to 10 days followed by administration of tylosin phosphate in medicated swine feed for 2 to 6 weeks for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis. Notice of the approval was published December 18, 2008.
  • TYLAN (tylosin tartrate) Soluble (supplement to NADA 013 076), filed by Elanco Animal Health, A Division of Eli Lilly & Co., Indianapolis, IN. The supplement provides for use of tylosin tartrate in medicated drinking water for swine for 3 to 10 days followed by administration of tylosin phosphate in medicated swine feed for 2 to 6 weeks for the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis. Notice of the approval was published December 18, 2008.

 

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

  • VETAZINE Cream (triamcinolone acetonide) (ANADA 200-459), filed by Modern Veterinary Therapeutics, LLC, Coral Gables, FL. The ANADA provides for veterinary prescription use of Cream on dogs for topical treatment of allergic dermatitis and summer eczema. Modern Veterinary Therapeutics, LLC’s VETAZINE Cream is approved as a generic copy of VETALOG Cream, sponsored by Fort Dodge Animal Health, A Division of Wyeth Holdings Corp., under NADA 046-146. Notice of the approval was published December 29, 2008.