• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

Approvals for April and May 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No II

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

VETMEDIN (pimobendan) Chewable Tablets (NADA 141-273), filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the use of VETMEDIN Chewable Tablets in dogs for the management of the signs of mild, moderate, or severe (modified New York Heart Association Class II, III, or IV) congestive heart failure due to atrioventricular valvular insufficiency or dilated cardiomyopathy. VETMEDIN is indicated for use with concurrent therapy (e.g., furosemide, etc.) for congestive heart failure as appropriate on a case-by-case basis. Notice of approval was published May 17, 2007.

PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets (NADA 141-268), filed by Schering-Plough Animal Health Corp. The NADA provides for the use of PROTAZIL in horses for the treatment of equine protozoal myeloencephalitis caused by Sarcocystis neurona. Notice of approval was published April 27, 2007.

WORMXPLUS (praziquantel and pyrantel pamoate) Flavored Chewables and VIRBANTEL (praziquantel and pyrantel pamoate) Flavored Chewables (NADA 141- 261), filed by Virbac NH, Inc. The NADA provides for the use of both products in dogs and puppies for the treatment and control of various internal parasites (i.e., Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocephala); and tapeworms (Dipylidium caninum, Taenia pisformis). Notice of approval was published April 4, 2007.

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

AQUAFLOR (florfenicol) (NADA 141-246), filed by Schering-Plough Animal Health Corporation. The supplemental NADA provides for the use of Aquaflor (florfenicol), a type A medicated article, by veterinary feed directive (VFD) to formulate type C medicated feed for the control of mortality in freshwater- reared salmonids due to coldwater disease associated with Flavobacterium psychrophilium. The single VFD order form for florfenicol includes both catfish and freshwater-reared salmonid indications because each comprises multiple species and is approved in each for use under similar directions and conditions of use. Notice of approval was published April 20, 2007.

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

BUTORPHANOL TITRATE INJECTION (2mg/mL) (ANADA 200-408), filed by IVX Animal Health, Inc. The ANADA provides for the use of Butorphanol Titrate Injection (2mg/mL) for veterinary prescription use in cats for the relief of pain. The product is approved as a generic copy of TORBUGESIC-SA (butorphanol titrate, USP), approved under NADA 141-047, held by Fort Dodge Animal Health, a Division of Wyeth. Notice of the ANADA approval was published May 18, 2007.

SUPERIORBUTE (phenylbutazone) Powder (ANADA 200-333), filed by Superior Equine Pharmaceuticals, Inc. The ANADA provides for the use of SUPERIORBUTE Powder administered to horses in feed for the relief of inflammatory conditions associated with the musculoskeletal system. SUPERIORBUTE Powder is approved as a generic copy of IVX Animal Health, Inc.’s Phenylbutazone Tablets, USP, approved under NADA 91-818. Notice of approval was published May 18, 2007.

NOROMECTIN Plus (ivermectin and clorsulon) Injection for Cattle (ANADA 200- 436), filed by Norbrook Laboratories Ltd. The ANADA provides for the use of NOROMECTIN Plus Injection for Cattle by subcutaneous injection for the control of various internal and -external parasites. It is approved as a generic copy of Merial Ltd.’s IVOMEC Plus Injection for Cattle (NADA 140-833). The firm’s NOROMECTIN (ivermectin) Injection for Cattle and Swine (ANADA 200-437) was also approved. The ANADA provides for the use of this drug by subcutaneous injection in cattle, swine, reindeer, and American bison for the treatment and control of various internal and external parasites. This ANADA is approved as a generic copy of Merial’s IVOMEC Injection for Cattle and Swine, which was approved under NADA 128-409. Notice of both ANADA approvals was published May 17, 2007.

TETROXY Aquatic (oxytetracycline hydrochloride) Soluble Powder (ANADA 200- 460), filed by Cross Vetpharm Group Ltd. The ANADA provides for the use of TETROXY Aquatic for skeletal marking of finfish fry and fingerlings by immersion. Notice of approval was published May 9, 2007.

CLINDAMYCIN HYRDOCHLORIDE Oral Drops (ANADA 200-418), filed by First Priority, Inc. The ANADA provides for the use of Clindamycin Hydrochloride Oral Drops in dogs and cats for the treatment of various skin and dental infections due to susceptible bacterial pathogens. The newly approved product is approved as a generic copy of Antirobe Aquadrops Liquid, sponsored by Pharmacia & Upjohn Co., a division of Pfizer, Inc., under NADA 135-940. Notice of approval was published April 20, 2007.

MURICIN (mupirocin) Ointment 2% (ANADA 200-418), filed by Altana, Inc. The ANADA provides for the use of mupirocin ointment 2% for the treatment of bacterial skin infections in dogs. The drug is approved as a generic copy of Pfizer, Inc.’s, BACTODERM Ointment, approved under NADA 140-839. Notice of approval was published April 11, 2007.

HEIFERMAX 500 (melengestrol acetate) Liquid Premix and BOVATEC (lasalocid sodium) single-ingredient Type A medicated articles to make dry and liquid, two-way combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter. ANADA 200-451 was filed by Ivy Laboratories, a Division of Ivy Animal Health, Inc. The ANADA is approved as a generic copy of NADA 140-288, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., for combination use of MGA 500 and BOVATEC. -Notice of approval was published April 4, 2007.