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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for March and April 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No I

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

  • POULTRYSULFA (sulfamerazine, sulfamethazine, and sulfaquinoxaline) Antimicrobial Soluble Powder (NADA 100-094), filed by Alpharma, Inc. The NADA provides revised labeling for an over-the-counter soluble powder containing sulfamerazine, sulfamethazine, and sulfaquinoxaline used in drinking water of chickens and turkeys as an aid in the control of coccidiosis and acute fowl cholera. The NADA relies on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group’s (DESI) effectiveness evaluation and subsequent Food and Drug Administration (FDA) conclusions. The findings were published in the Federal Register of July 5, 1984 (49 FR 27543). Using the official analytical method of detection, residues of sulfamethazine and sulfamerazine in edible tissues co-elute and cannot be quantified individually. There are no products containing only sulfamerazine approved for use in chickens or turkeys. Therefore, a tolerance for sulfamerazine residues in edible tissues of chickens or turkeys is not established at this time. Products that comply with the NAS/NRC findings and FDA’s conclusions regarding those findings are eligible for immediate copying under the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) (see the eighth in a series of policy letters issued to facilitate implementation of GADPTRA that published in the Federal Register of August 21, 1991 [56 FR 41561]) and is available online at www.fda.gov/cvm/Documents/8thltr.doc. Notice of approval of NADA 100-094 was published March 14, 2006.
  • BOVATEC (lasalocid sodium) and AUREOMYCIN (chlortetracycline) Type A medicated articles to formulate two-way combination drug Type B and Type C medicated feeds (NADA 141-250), filed by Alpharma, Inc. The NADA provides for use of approved single-ingredient Type A medicated articles containing lasalocid and chlortetracycline to formulate two-way combination drug Type B and Type C medicated feeds for pasture cattle and cattle fed in confinement for slaughter. Notice of approval was published April 27, 2006.

CVM has published in the Federal Register notice of the approval of these Supplemental NADAs

  • SAFE-GUARD (fenbendazole) Canine (NADA 121-473), filed by Intervet, Inc. The supplemental NADA provides for minor changes to the labeling of over-the-counter fenbendazole orally administered granules used for the treatment and control of certain internal parasites in dogs. The drug is indicated for use in adult dogs and puppies, six weeks of age or older, for the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis). Notice of approval was published April 14, 2006.
  • PENNCHLOR (chlortetracycline) Type A medicated articles (NADA 138-935), filed by Pennfield Oil Co. The supplemental NADA provides for a 0-day withdrawal time before slaughter when Type C medicated feeds containing chlortetracycline are fed to cattle. PENNCHLOR (chlortetracycline) Type A medicated article is used for making -medicated feeds for the treatment of various bacterial diseases of livestock. It is indicated in beef cattle for the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; in beef cattle (under 700 lbs.) for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; for beef cattle (over 700 lbs.) for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; for calves, beef, and nonlactating dairy cattle for treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for breeding sheep for reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline; for swine for reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline; for breeding swine for the control of leptospirosis (reducing the instances of abortions and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline; for swine for treatment of bacterial enteritis caused by Escherichia coli and Salmonella cholerasuis, and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for chickens for control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline; for chickens for control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline; for chickens for reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline; for turkeys for control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline; for turkeys for control of hexamitiasis caused by Hexamita meleagrides susceptible to chlortetracycline; for turkey poults not over 4 weeks of age for reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline; and for turkeys for control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline. Notice of approval was published April 7, 2006.
  • ORBAX (orbifloxacin) Tablets (NADA 141-081), filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for revised animal safety labeling for orbifloxacin tablets used in dogs and cats for the management of diseases associated with susceptible bacteria. Specifically, the revisions include the addition of post-approval adverse drug experience information and fluoroquinolone class statements regarding retinal toxicity in cats. Notice of approval was published March 23, 2006.

CVM has published in the Federal Register notice of the approval of these Abbreviated NADAs (ANADA)

  • HEIFERMAX 500 (melengestrol acetate) Liquid Premix and RUMENSIN (monensin sodium) single-ingredient Type A medicated articles to make two-way combination drug Type C medicated feeds (ANADA 200-422), filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and monensin to make two-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200-422 is approved as a generic copy of Pharmacia and Upjohn’s NADA 125-476 for combination use of MGA 500 (melengestrol acetate) Liquid Premix and RUMENSIN in cattle feed. Notice of approval was published April 21, 2006.
  • FLUNAZINE (flunixin meglumine) Injectable Solution (ANADA 200-387), filed by Cross Vetpharm Group Ltd. The ANADA provides for the veterinary prescription use of flunixin meglumine injectable solution for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. In cattle it is indicated for the control of pyrexia associated with bovine respiratory disease and endotoxemia, and is also indicated for the control of inflammation in endotoxemia. Cross Vetpharm Group’s Flunixin Injectable Solution is approved as a generic copy of Schering-Plough Animal Health’s BANAMINE (flunixin) Solution, approved under NADA 101-479. Notice of approval was published March 31, 2006.

CVM has published in the Federal Register notice of the approval of these Supplemental ANADAs

  • TRI-OTIC (gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP) Ointment (ANADA 200-229), filed by Med-Pharmex, Inc., that provides for the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin. The supplemental ANADA provides for a new container size, a 15-g bottle. Notice of approval was published April 3, 2006.
  • Flunixin (flunixin meglumine) Injection (ANADA 200-308), filed by Norbrook Laboratories. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of fever associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia. Notice of approval was published March 29, 2006.