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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for October and November 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No V

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

NUFLOR (florfenicol) (NADA 141-264), filed by Schering-Plough Animal Health Corp. The NADA provides for the Veterinary Feed Directive use of this antibiotic, a Type A medicated article to formulate Type C medicated feeds used for the control of swine respiratory disease (SRD) associated with several bacteria. These bacteria consist of Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD. Notice of approval was published December 4, 2006.

IVERHART MAX (ivermectin, pyrantel, pamoate, praziquantel) Chewable Tablets (NADA 141-

257), filed by Virbac AH, Inc. The NADA provides for veterinary prescription use for dogs of chewable tablets containing ivermectin, pyrantel pamoate, and praziquantel for the treatment and control or prevention of various internal parasites. Specifically, the new product prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and is approved for the treatment and control of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections. Notice of approval was published November 7, 2006.

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

LINCOMYCIN-SPECTINOMYCIN (lincomycin hydrochloride and spectinomycin dihydrochloride pentahydrate) (ANADA 200-407), filed by Agri Laboratories, Ltd. The ANADA provides for use of Lincomycin-Spectinomycin (lincomycin hydrochloride and spectinomycin dihydrochloride pentahydrate) Water Soluble Powder to create a solution administered in the drinking water of chickens as an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin. The ANADA is approved as a generic copy of L-S 50 Water Soluble Powder, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 046-109. Notice of approval was published December 8, 2006.

PRIMEX (Prantel pamoate) ANADA 200-445), filed by First Priority, Inc. The ANADA provides for the oral use of pyrantel pamoate Horse Wormer in horses and ponies as an OTC animal drug product for the removal and control of various internal parasites. First Priority, Inc.’s, PRIMEX Horse Wormer is approved as a generic copy of Pfizer, Inc.’s, PAMOBAN Horse Wormer, approved under NADA 91-739. Notice of approval was published December 4, 2006.

SMZ-MED 454 (ANADA 200-434), filed by Cross Vetpharm Group Ltd. The ANADA provides for the use of (sulfamethazine sodium) Soluble Powder to create a solution -administered as a drench to swine or cattle, or in the drinking water of chickens, turkeys, swine, or cattle for the treatment of coccidiosis or various bacterial diseases. The new product is approved as a generic copy of Fort Dodge Animal Health, a Division of Wyeth Holdings Corp.’s, SULMET Soluble Powder, which was approved under NADA 122-272. Notice of approval was published December 4, 2006.

GLYCOPYRROLATE INJECTABLE (ANADA 200-365), filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of Glycopyrrolate Injectable as a preanesthetic agent in dogs and cats. The new product is approved as a generic copy of Fort Dodge Animal Health’s (a Division of Wyeth) ROBINUL-V (glycopyrrolate), approved under NADA 101-777. Notice of approval was published November 2, 2006.

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

TYLAN (tylosin) (supplement to NADA 12-491), filed by Elanco Animal Health, a Division of Eli Lilly & Co. The supplement provides for the use of tylosin phosphate Type A medicated articles and provides for an alternate feeding regimen for the control of swine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. In addition, Elanco Animal Health revised the names on labeling of other enteric pathogens of swine to reflect changes in the scientific nomenclature for these bacteria. Notice of approval was published December 12, 2006.

BOVATEC 91 (lasalocid) (supplement to NADA 96-298), filed by Alpharma Inc. The supplement provides for the use of lasalocid Type A medicated article (20 percent lasalocid activity per pound) to make free-choice Type C medicated feeds used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Notice of approval was published -November 21, 2006.

PAYLEAN (ractopamine hydrochloride) (supplement to NADA 141-863), filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplement provides for the use of ractopamine hydrochloride Type A medicated articles in Type B and C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine. The supplement revises the concentrations of ractopamine hydrochloride fed to finishing swine, weighing not less than 150 pounds, fed a complete ration containing at least 16 percent crude protein for the last 45 to 90 pounds of gain prior to slaughter. Elanco Animal Health also filed a supplement to NADA 141-172 that provides for use of two-way combination Type C medicated swine feeds formulated with ractopamine hydrochloride and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles. The supplement revises the concentrations of ractopamine hydrochloride in Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and for the prevention and/or control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis and for the prevention of swine dysentery (vibrionic) in finishing swine weighing not less than 150 pounds, fed a complete ration containing at least 16 percent crude protein for the last 45 to 90 pounds of gain prior to slaughter. Notice of approval for both supplements was published November 21, 2006.

ULCERGARD (omeprazole) Paste (NADA 141-227), filed by Merial Ltd. The supplemental NADA provides for the administration of omeprazole paste to horses for 8 or 28 days for the prevention of gastric ulcers. The drug is available for over-the-counter lay use because a diagnosis of gastric ulcer disease is not required for use of the drug to prevent the disease. Notice or approval was published October 10, 2006.

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

OXYTETRACYCLINE HCl Soluble Powder-343 (ANADA 200-247), filed by IVX Animal Health, Inc. The supplemental ANADA provides for the use of Oxytetracycline HCl Soluble Powder-343 in several species. The supplement revises labeling of generic oxytetracycline soluble powder with the current scientific names of the causative bacteria of foulbrood of honeybees. Approval of this supplemental ANADA did not require review of additional safety or effectiveness data or information. Notice of approval for the supplement was published December 8, 2006.