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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 2001

FDA Veterinarian Newsletter July/August 2001 Volume XVI, No IV

Company

Generic and (Brand) Names 

Indications 

Routes/Remarks 

 

Alpharma, Inc.

(NADA 96-298)

Lasalocid (Avatec®)

Chickens, Turkeys. For prevention of coccidiosis.

MEDICATED FEED—The supplement provides for establishing tolerances for residues of lasalocid in edible tissues of chickens and turkeys. In addition, the acceptable daily intake (ADI) is codified and a tolerance is established for residues of lasalocid in sheep liver.

Federal Register04/18/01

 

Alpharma, Inc.

(130-435)

Oxytetracycline hydrochloride (Oxytet)

Turkeys, Swine. For treatment of various bacterial diseases of livestock.

ORAL—The supplement provides for a revised withdrawal time for use of oxytetracycline hydrochloride soluble powder in the drinking water. The NADA provides for a zero-day slaughter withdrawal time.

Federal Register04/30/01

 

Pharmacia and Upjohn Co.

(NADA 140-338)

Ceftiofur sodium (Naxcel®) Rx

Goats. For treatment of goat pneumonia.

INTRAMUSCULAR—The supplement provides for use of Naxcel sterile powder for injection for treatment of caprine respiratory disease associated with Pasteurella haemolytica and P. multocida.

Federal Register04/30/01

 

Elanco Animal Health

Division of Eli Lilly & Co.

(NADA 118-980)

Narasin (Monteban®)

Chickens. For the prevention of coccidiosis.

MEDICATED FEED—The supplement provides for establishing a tolerance for residues of narasin in the abdominal fat of chickens and for codifying the acceptable daily intake (ADI) for total residues of narasin.

Federal Register05/09/01

 

Pfizer, Inc.

(NADA 8-622)

Oxytetracycline hydrochloride (Terramycin®)

Swine. For the treatment of various bacterial diseases of livestock.

ORAL—The supplement provides for a revised withdrawal time for use of oxytetracycline hydrochloride soluble powder in the drinking water. The supplement provides for a zero-day slaughter withdrawal time.

Federal Register 05/29/01