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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for November - December 2007 and January 2008

FDA Veterinarian Newsletter 2007 Volume XXII, No VI

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

  • SIMPLICEF 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 approval was published January 4, 2008.

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

  • CEFA-LAK (cephapirin sodium) and TODAY (cephapirin sodium) Intramammary Infusion (supplements to NADA 97-222), filed by Fort Dodge Animal Health, Fort Dodge, IA. The supplemental NADAs provides for the use of CEFA-LAK (cephapirin sodium) and TODAY (cephapirin sodium) Intramammary Infusion for administering to lactating cows for the treatment of mastitis. Notice of ap-proval was published January 17, 2008.
  • PREVICOX (firocoxib) Chewable Tablets (supplement to NADA 141-230), filed by Merial Ltd., Duluth, GA. The supplemental appli-cation provides for the veterinary prescription use of firocoxib Chewable Tablets in dogs for the control of post-operative pain and inflammation associated with soft-tissue surgery. Notice of approval was published January 16, 2008.
  • PIRSUE (pirilimycin hydrochloride) Sterile Solution (supplement to NADA 141-036), filed by Pharmacia & Upjohn Co., New York, NY. The supplemental NADA provides for the veterinary prescription use of PIRSUE (pirilimycin hydrochloride) Sterile Solution in lactating dairy cattle for the treatment of mastitis. The supplement extends the dosage regimen to daily treatment for up to 8 days. Notice of approval was published January 4, 2008.
  • OPTAFLEXX (ractopamine hydrochloride), MGA (melengestrol acetate), and RUMENSIN (monensin USP) (supplement to NADA 141-234), filed by Elanco Animal Health, Indianapolis, IN. The supplemental NADA provides for the use of OPTAFLEXX (racto-pamine hydrochloride), MGA (melengestrol acetate), and RUMENSIN (monensin USP) Type A medicated articles to make dry and liquid three-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; and for suppression of estrus (heat) 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. Notice of approval was published December 13, 2007.
  • PENNOX (oxytetracycline) (supplement to NADA 138-938), filed by Pennfield Oil Co., Omaha, NE. The supplemental NADA pro-vides for the use of PENNOX (oxytetracycline) Type A medicated articles used for making medicated feeds for the treatment of various bacterial diseases of livestock and fish. The supplemental NADA provides for a zero-day withdrawal time prior to slaugh-ter when Type C medicated feeds containing oxytetracycline are fed to turkeys or swine and for minor label revisions. Notice of approval was published December 13, 2007.
  • GALLIMYCIN-100 (erythromycin) Injection (supplement to NADA 12-123), filed by Cross Vetpharm Ltd., Dublin, Ireland. The sup-plemental NADA provides for the use of a 100 mg/mL strength of GALLIMYCIN-100 (erythromycin) injectable solution in cattle for the treatment of bovine respiratory disease. Notice of approval was published December 7, 2007.
  • RUMENSIN (monensin USP) and TYLAN (tylosin phosphate) (supplement to NADA 104-646), filed by Elanco Animal Health, Indianapolis, IN. The supplemental NADA provides for the use of RUMENSIN (monensin USP) and TYLAN (tylosin phosphate) Type A medicated articles to make dry and liquid two-way combination medicated feeds for cattle fed in confinement for slaugh-ter. The supplemental NADA provides for an increased level of monensin in combination Type B and Type C medicated feeds and a revision to bacterial pathogen nomenclature. Notice of approval was published December 5, 2007.
  • RUMENSIN 80 (monensin) (supplement to NADA 95-735), filed by Elanco Animal Health, Indianapolis, IN. the supplemental NADA provides for use of RUMENSIN 80 (monensin) Type A medicated articles, specifically removing the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats. Notice of approval was pub-lished December 5, 2007.
  • SAFE-GUARD (fenbendazole) (NADA 131-675), filed by Intervet Inc., Millsboro, DE. SAFE-GUARD (fenbendazole) 20% Type A medicated article is approved to formulate Type B and Type C medicated horse feeds. The approved supplemental NADA pro-vides for a revised food safety warning on the labeling. Notice of approval was published November 27, 2007.
  • AQUAFLOR (florfenicol) (NADA 141-246), filed by Schering-Plough Animal Health Corp., Summit, NJ. The approved supplemental NADA provides for the use of AQUAFLOR (florfenicol), a Type A medicated article, by veterinary feed directive to formulate Type C medicated feed for the control of mortality in freshwater-reared salmonids due to furunculosis with Aeromonas salmonicida. No-tice of approval was published November 26, 2007.
  • OPTAFLEXX (ractopamine hydrochloride) and RUMENSIN (monensin USP) (NADA 141-225), filed by Elanco Animal Health, a Division of Eli Lilly & Co., Indianapolis, IN. The approved supplemental NADA provides for the use of OPTAFLEXX (ractopamine hydrochloride) and RUMENSIN (monensin USP) Type A medicated articles to make dry and liquid two-way combination medi-cated feeds for cattle fed in confinement for slaughter. The supplemental NADA provides for an increased level of monensin in combination Type B and Type C medicated feeds. Notice of approval was published November 23, 2007.
  • AUREOMYCIN (chlortetracycline) Soluble Powder Concentrate (NADA 65-440), filed by Fort Dodge Animal Health, Fort Dodge, IA. The approved supplemental NADA provides label revisions for the use of AUREOMYCIN (chlortetracycline) Soluble Powder Concentrate. The product is approved for oral use in medicated drinking water of chickens, growing turkeys, swine, calves, beef cattle, and nonlactating dairy cattle for the control and/or treatment of various bacterial diseases. Notice of approval was pub-lished November 14, 2007.
  • OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin USP), and TYLAN (tylosin phosphate) (NADA 141-22), filed by Elanco Animal Health, Indianapolis, IN. The approved supplemental NADA provides for the use of OPTAFLEXX, RUMENSIN, and TYLAN Type A medicated articles to make dry and liquid three-way combination medicated feeds for cattle fed in confine-ment for slaughter. The supplemental NADA provides for an increased level of monensin in combination Type C medicated feeds and a revision to bacterial pathogen nomenclature. Notice of approval was published November 6, 2007.

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

  • CLINDAROBE (clindamycin hydrochloride) Capsules (ANADA 200-383), filed by Novapharm Ltd., Toronto, Ontario, Canada. The ANADA provides for the veterinary prescription use of CLINDAROBE (clindamycin hydrochloride) Capsules in dogs for the treat-ment of various infections due to susceptible bacterial pathogens. Novopharm’s CLINDAROBE Capsules are approved as a ge-neric copy of Pharmacia & Upjohn Company’s ANTIROBE Capsules, approved under NADA 120-161. Notice of approval was published January 24, 2008.
  • VETPROFEN (carprofen) Caplets (ANADA 200-397), filed by Belcher Pharmaceuticals, Largo, FL. The ANADA provides for vet-erinary prescription use in dogs for the relief of pain and inflammation associated with osteoarthritis, and for the control of post-operative pain associated with soft tissue and orthopedic surgeries. VETPROFEN Caplets are approved as a generic copy of RI-MADYL Caplets, sponsored by Pfizer, Inc., under NADA 141-053. Notice of approval was published December 5, 2007.

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

  • FLUNIXIN INJECTION (ANADA 200-308), filed by Norbrook Laboratories, Newry, Northern Ireland. The approved supplemental ANADA provides for the veterinary prescription use of FLUNIXIN INJECTION intravenously in lactating dairy cattle for the control of pyrexia associated with acute bovine mastitis. Notice of approval was published January 16, 2008.
  • NOROMECTIN (ivermectin) Injection (ANADA 200-437), filed by Norbrook Laboratories, Newry, Northern Ireland. The approved supplemental ANADA for Noromectin (ivermectin) Injection for Cattle and Swine adds claims for persistent effectiveness against various species of external and internal parasites of cattle. These include gastrointestinal roundworms, lungworms, grubs, suck-ing lice, and mange mites. Notice of approval was published November 7, 2007.