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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - July/August 2000

FDA Veterinarian Newsletter July/August 2000 Volume XV, No IV

CompanyGeneric and Brand NamesIndicationsRoutes/Remarks

Biopure Corp.

(NADA 141-067)

Hemoglobin Glutamer-200 (Bovine) (Oxyglobin®)Dogs. For the treatment of anemia.

INTRAVENOUS: The supplemental NADA provides for flexible dosing for use of hemoglobin glutamer-200 (bovine) to treat anemia in dogs. The drug increases systemic oxygen content and improves the clinical signs associated with anemia, regardless of the cause. The supplement provides for use of 10 to 30 ml per kilogram of body weight administered at 10 ml/kg/hour.

Federal Register: 04/18/00

Fort Dodge Animal Health

(NADA 97-222)

Cephapirin Sodium (CEFA-LAK® and TODAY®)Dairy Cattle. Treatment of lactating cows for bovine mastitis.

INTRAMAMMARY: The supplement amends the milk discard statement by stating the milk discard time only and dropping the reference to number of milkings.

Federal Register: 04/18/00

Hoechst Roussel Vet

(NADA 131-675)

Fenbendazole (Safe-Guard®)Swine. Treatment regimen for removal of lungworms, large roundworms, nodular worms, small stomach worms, whipworms, and kidneyworms.

MEDICATED FEED: The supplement provides for establishing tolerances for parent fenbendazole in swine liver and muscle. An ADI is also added. The tolerance in swine liver is 6 ppm and in muscle 2 ppm.

Federal Register: 04/18/00

Fort Dodge Animal Health

(NADA (141-099)

Moxidectin (Cydectin®)Dairy Cattle. For treatment and control of infections and infestations of certain internal and external parasites

TOPICAL: The supplement provides for topical use of a 0.5 % moxidectin solution on dairy cattle of breeding age. It also establishes a tolerance for moxidectin residues in milk.

Federal Register: 06/09/00