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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 2004

FDA Veterinarian Newsletter July/August 2004 Volume XIX, No IV

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Fort Dodge Animal Health, Division of Wyeth
(NADA 141-087)
Moxidectin 2.0% (Quest Gel)
Horses. For the treatment and control of various species of internal parasites in horses and ponies.
ORAL—The supplemental NADA provides for the addition of one new species of adult small strongyle and for the speciation of adult small strongyles.
Federal Register 05/05/04

Merial Ltd.
(NADA 140-833)
Ivermectin and Clorsulon (Ivomec Plus Injection)
Cattle. For the protection from re-infection with three species of internal parasites following administration.
INJECTABLE—The supplemental NADA provides for an increased period of protection by extending the period of persistent effectiveness for Oesophagostomum radiatum to 28 days after treatment, and for Cooperia punctata and Trichostrongylus axei to 21 days after treatment. A veal calf warning statement is being added because residue depletion data for this class of cattle has not been submitted to the application.
Federal Register 06/07/04

Phibro Animal Health
(NADA 008-804)
Oxytetracycline (TM-50, TM-5OD, TM-100, TM-100D Type A Medicated Articles)
Calves, beef cattle and nonlactating dairy cattle. Type A medicated articles to be used for making medicated feeds for the treatment of various bacterial diseases of livestock.
MEDICATED FEED—The supplemental NADA provides for a 0-day withdrawal time prior to slaughter when Type C medicated feeds containing oxytetracyline are fed continuously to calves, beef cattle and nonlactating dairy cattle at a dosage of 10 milligrams per pound of body weight for up to 14 days.
Federal Register 05/19/04

Phibro Animal Health
(NADA 095-143)
Oxytetracycline (Terramycin 50, Terramycin 100, and Terramycin 200 Type A Medicated Articles)
Calves, beef cattle and nonlactating dairy cattle. Type A medicated articles to be used for making medicated feeds for the treatment of various bacterial diseases of livestock.
MEDICATED FEED—The supplemental NADA provides for a 0-day withdrawal time prior to slaughter when Type C medicated feeds containing oxytetracyline are fed continuously to calves, beef cattle and nonlactating dairy cattle at a dosage of 10 milligrams per pound of body weight for up to 14 days.
Federal Register 05/19/04