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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for July through September 2005

FDA Veterinarian Newsletter July/August 2005 Volume XX, No IV

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

DRAXXIN (tulathromycin) Injectable Solution (NADA 141-244), filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of tulathromycin solution in cattle, by subcutaneous injection, for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella mulitocida, and Histophilus somni (Haemophilus somnus); for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni; and in swine, by intramuscular injection, for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis. The regulations are also amended to add the acceptable daily intake for total residues of tulathromycin and tolerances for residues of tulathromycin in edible tissues of cattle and swine. Notice of approval was published July 12, 2005.

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

DECTOMAX (doramectin) Pour-On Solution for Cattle (NADA 141-095), filed by Pfizer, Inc. The supplemental application provides for a period of protection from reinfestation with two species of external parasites following topical administration of doramectin solution on cattle. Specifically, the period of persistent effectiveness is 42 days for Linognathus vituli and 77 days for Bovicola (Damalinia) bovis. Notice of approval was published July 26, 2005.

TERRAMYCIN-343 (oxytetracycline HCl) Soluble Powder (NADA 8-622), filed by Pfizer, Inc. The supplemental NADA provides for use of the product for skeletal marking of finfish fry and fingerlings by immersion. The approval of this supplemental NADA relied on publicly available safety and effectiveness data contained in Public Master File (PMF) 5667, which were compiled under National Research Support Project-7 (NRSP-7), a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for special uses. The supplemental NADA also provides for the addition of statements to product labeling warning against the use of this product in drinking water of lactating dairy cattle. In addition, FDA has found that the regulations contain incorrect statements warning against the use of oxytetracycline soluble powder in calves intended for veal. Accordingly, the regulations in 21 CFR 520.1660d are amended to reflect appropriate warning statements for this product. This action is being taken to improve the accuracy of the regulations. Notice of approval was published July 18, 2005.

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

Phenylbutazone 20% Injection (phenylbutazone) (ANADA 200-371), filed by Sparhawk Laboratories, Inc. The ANADA provides for veterinary prescription use of Phenylbutazone 20% Injection for relief of inflammatory conditions associated with the musculoskeletal system in horses. Sparhawk Laboratories, Inc.’s product is approved as a generic copy of Schering-Plough Animal Health Corp.’s, BUTAZOLIDIN Injectable 20%, approved under NADA 11-575. Notice of approval was published August 17, 2005.

Tiamulin Liquid Concentrate (12.3% tiamulin hydrogen fumarate) (ANADA 200-360), filed by Phoenix Scientific, Inc. The ANADA provides for use of tiamulin concentrate solution to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia. Phoenix Scientific, Inc.’s Tiamulin Liquid Concentrate is approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s DENAGARD (tiamulin) Liquid Concentrate approved under NADA 140-916. Notice of approval was published July 26, 2005.

Speclinx-50 (spectinomycin dihydrochloride pentahydrate and lincomycin hydrochloride monohydrate) Water Soluble Powder (ANADA 200-380), filed by Cross Vetpharm Group Ltd. This ANADA provides for use of SPECLINX-50 Water Soluble Powder to create a solution administered through the drinking water of chickens. This solution acts 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. Cross Vetpharm Group Ltd.’s SPECLINX-50 Water Soluble Powder is approved as a generic copy of Pharmacia & Upjohn Co.’s L-S 50 Water Soluble Powder, approved under NADA 046-109. Notice of approval was published July 15, 2005.

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

Flunixin Meglumine (flunixin meglumine ) Injection (ANADA 200-124), filed by Phoenix Scientific, Inc. The supplemental ANADA provides for 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 August 22, 2005.