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U.S. Department of Health and Human Services

Animal & Veterinary

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New Animal Drug Approvals - May/June 1998

FDA Veterinarian Newsletter May/June 1998 Volume XIII, No III

Company: Hoechst Roussel Vet (NADA 140-843)
Generic and (Brand) Names: Narasin, Bambermycins and Roxarsone
Indications: Broiler chickens. To prevent coccidiosis, increased rate of weight gain, improved feed efficiency, and improved pigmentation.

Routes/Remarks: MEDICATED FEED: Provides for using approved single ingredient Type A medicated articles, Monteban (45 grams narasin activity per pound), Flavomycin (4 and 10 g bambermycins activity/lb), and 3-Nitro(45.4, 90, and 227g roxarsone/lb), to make Type C medicated broiler feed containing 54 to 72 g narasin, 1 to 2 g bambermycins, and 22.7 to 45.4g roxarsone/ton of feed. Federal Register 3/18/98.

Company: Biopure Corp. (NADA 141-067)
Generic and (Brand) Names: Hemoglobin Glutamer-200 (bovine) (Oxyglobin®) Rx
Indications: Dogs. For the treatment of anemia.
Routes/Remarks: INTRAVENOUS: Each 125 milliliter bag contains 13 grams per deco-liter of sterile, polymerized hemoglobin of bovine origin in modified Lactated Ringer's Solution. Federal Register 3/10/98.

Company: Heska Corp. (NADA 141-082)
Generic and (Brand) Names: Doxycycline Hyclate solution Rx
Indications: Dogs. For treatment and control of periodontal disease.
Routes/Remarks: SUBGINGIVAL: Solution to be applied by syringe to the periodontal pockets of the affected teeth. Do not use in dogs less than 1 year old. Do not use in pregnant bitches. Federal Register 2/19/98.

Company: Fort Dodge Animal Health (NADA 141-096)
Generic and (Brand) Names: Difloxacin Hydrochloride (Dicural®) Rx
Indications: Dogs. For managing diseases in dogs associated with bacteria susceptible to difloxacin. Federal law prohibits extralabel use of drug in food-producing animals.
Routes/Remarks: ORAL: Each tablet contains 11.4, 45.4, or 136 milligrams. Amount used is 5 to 10 mg per kilogram of body weight. Federal Register 2/18/98.

Company: Fort Dodge Animal Health (NADA 141-099)
Generic and (Brand) Names: Moxidectin (Cydectin ®)
Indications: Cattle. For treatment and control of infections and infestations of certain internal and external parasites.
Routes/Remarks: TOPICAL: Provides for a 0.5% solution as a pour-on for beef and non-lactating dairy cattle at 500 micrograms per kilogram body weight. Also establishes an ADI of 4 mg/kg/day and tolerance in cattle of 50 ppb inmuscle and 200 ppb in liver. Federal Register 3/24/98.

Company: Novartis Animal Health U.S., Inc. (NADA 141-029)

Generic and (Brand) Names: Desoxycorticosterone pivalate (Percorten-V®) Rx
Indications: Dogs. For replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.
Routes/Remarks: INTRAMUSCULAR: Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days. Federal Register 3/18/98.

Company: Alpharma, Inc. (NADA 141-069)
Generic and (Brand) Names: Colistimethate sodium (First Guard ® Sterile Powder) Rx
Indications: 1-3 day old Chickens. For control of early mortality associated with Escherichia coli organisms.
Routes/Remarks: SUBCUTANEOUS: The sterile powder is reconstituted in sterile saline or sterile water for injection in the neck of the chicks. Federal Register 3/18/98.

 

ABBREVIATED NEW ANIMAL DRUG APPROVALS

Company: Hoffmann-LaRoche, Inc. (ANADA 200-242)
Generic and (Brand) Names: Chlortetracycline, Bacitracin Methylene Disalicylate
Indications: Swine. For treatment of bacterial enteritis, bacterial pneumonia, increased weight gain, improved feed efficiency.
Routes/Remarks: MED FEED: ANADA 200-242 is a generic copy of Alpharma, Inc.'s NADA 141-059. Federal Register 3/3/98.

Company: Rhone-Poulenc Chemicals, Ltd. (ANADA 200-237)
Generic and (Brand) Names: Isoflurane Rx
Indications: Horses and dogs. As an inhalant for induction and maintenance of general anesthesia.
Routes/Remarks: INHALANT: ANADA 200-237 is a generic copy of Ohmeda Pharmaceutical Products Div., Inc.'s NADA 135-773 (Aerrane®). Federal Register 2/18/98.

Company: Company Western Chemical, Inc. (ANADA 200-226)
Generic and (Brand) Names: Tricaine Methane- Sulfonate
Indications: Fish and other aquatic animals. In the water for anesthesia and tranquilization.
Routes/Remarks: TOPICAL: ANADA 200-226 is a generic copy of Argent Chemical Laboratories' NADA 42-427 (Finquel®). Federal Register 2/17/98.

 

SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS

Company: Hoffmann-La Roche, Inc. (NADA 49-287)
Generic and (Brand) Names: Chlortetracycline (PfiChlor® 50, 70,100) CTC Type A Articles
Indications: Chickens, turkeys, sheep, calves, cattle, swine. For control and treatment of animal diseases susceptible to CTC, as well as weight gain and improved feed efficiency.
Routes/Remarks: MEDICATED FEED: The firm filed the supplemental application and labeling to reflect the concurrence with the conclusions of NAS/NRC DESI review and the subsequent FDA conclusions. Federal Register 3/31/98.

Company: Hoffmann-La Roche, Inc. (NADA 100-901)
Generic and (Brand) Names: Chlortetracycline (PfiChlor® 100S) CTC Type A Articles
Indications: Calves. For a calf milk replacer.
Routes/Remarks: MEDICATED FEED: The firm filed the supplemental application and labeling to reflect the concurrence with the conclusions of NAS/NRC DESI review and the FDA conclusions based on that review. Federal Register 3/31/98.

Company: Pfizer, Inc. (NADA 41-061)

Generic and (Brand) Names: Carbadox (Mecadox®)

Indications: Swine. For control of swine dysentery, control of swine enteritis, increased rate of weight gain, and improved feed efficiency.

Routes/Remarks: MED FEED: The supplement provides for a revised finite tolerance for residues of carbadox in edible swine tissue (30 ppb in liver) Federal Register 3/19/98.

Company: Pfizer, Inc. (NADA 55-099)

Generic and (Brand) Names: Amoxicillin Trihydrate and Clavulanate Potassium Tablets (Clavamox)

Indications: Dogs. For treatment of periodontal infections caused by susceptible strains of aerobic and anaerobic bacteria.

Routes/Remarks: ORAL, Tablets: The supplemental application revises the indications to include treatment of periodontal infections. Federal Register 3/18/98.

Company: Pfizer, Inc. (NADA 55-101)
Generic and (Brand) Names: Amoxicillin Trihydrate and Clavulanate Potassium Suspension (Clavamox)
Indications: Dogs. For treatment of periodontal infections caused by susceptible strains of aerobic and anaerobic bacteria.
Routes/Remarks: ORAL, Suspension: The supplemental application revises the indications to include treatment of periodontal infections. Federal Register 3/18/98.

Company: Elanco Animal Health (NADA 140-929)
Generic and (Brand) Names: Tilmicosin Phosphate (Micotil ® 300 Inj.) Rx
Indications: Cattle, including preruminating (veal) calves. For treatment of cattle with bovine respiratory disease(BRD)associated with Pasteurella haemolytica.
Routes/Remarks: SUBCUTANEOUS: This supplement provides for the removal of the label warnings concerning injection in veal calves. Federal Register 2/17/98.

Company: Merial Ltd. (NADA 128-409)
Generic and (Brand) Names: Ivermectin (Ivomec® Inj. 1%)
Indications: Cattle, Swine, Reindeer, and American Bison. For treatment and control of certain internal and external parasites.
Routes/Remarks: SUBCUTANEOUS: This supplemental NADA provides for use of 1% Ivermectin injection in American bison and a tolerance for residues of Ivermectin in edible tissues. Federal Register 2/17/98.

Company: Elanco Animal Health (NADA 95-735)
Generic and (Brand) Names: Monensin Pasture
Indications: Cattle. For increasing weight gain.
Routes/Remarks: MED FEED: This supplemental NADA incorporates the data from NADA 119-823 for a free choice feed. NADA 119-823 is withdrawn. Federal Register 2/11/98.