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U.S. Department of Health and Human Services

Animal & Veterinary

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Animal Drug Approvals - November/December 2005

FDA Veterinarian Newsletter November/December 2005 Volume XX, No VI

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

  • EQUIOXX (firocoxib) Oral Paste (NADA 141-253), filed by Merial Ltd. The NADA provides for veterinary prescription use of firocoxib oral paste in horses for the control of pain and inflammation associated with osteoarthritis. Notice of approval was published -February 3, 2006.

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

  • DURALEASE (estradiol benzoate) Microencapsulated Suspension Implant (NADA 141-040), filed by PR Pharmaceuticals, Inc. The supplemental NADA provides for subcutaneous injection, in the ear only, of a suspension implant of estradiol benzoate microspheres for increased rate of weight gain in suckling beef calves. It also adds the indication for use for increased rate of weight gain in steers fed in confinement for slaughter, previously approved at a lower dose, to the higher approved dose level. Notice of approval was published February 17, 2006.
  • CYDECTIN (moxidectin) Injectable Solution for Beef and Nonlactating Dairy Cattle (NADA 141-220), filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for use of an injectable moxidectin solution in cattle for the treatment and control of an additional three species of internal parasites and an additional three life stages of previously approved internal parasites. The six new therapeutic claims are for: Trichostrongylus colubriformis – Adult; Cooperia pectinata – Adult; Cooperia spatulata – Adult; Nematodirus helvetianus – Adult; Ostertagia ostertagi - L4; and Trichostrongylus axei - L4. Notice of approval was published February 13, 2006.
  • DRONTAL PLUS (praziquantel/pyrantel pamoate/febantel) Taste Tabs for Dogs (141-007), filed by Bayer HealthCare LLC, Animal Health Division. The supplemental NADA amends the approved NADA by adding a flavored chewable tablet formulation with the same indications. The tablets are indicated for the removal of Tapeworms (Dipylidum caninum, Taenia pisiformis, Echinococcus granulosus, and removal and control of Echinococcus multilocularis) and for removal of Hookworms (Ancylostoma caninum, Uncinaria stenocephala), Ascarids (Toxocara canis, Toxascaris leonina) and Whipworms (Trichuris vulpis) in dogs. Notice of approval was published February 9, 2006.
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