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U.S. Department of Health and Human Services

Animal & Veterinary

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New Animal Drug Approvals - May/June 2004

FDA Veterinarian Newsletter May/June 2004 Volume XIX, No 3

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Alpharma, Inc.
(NADA 141-223)
Diclazuril plus Roxarsone (Clinacox plus 3-Nitro)
Broiler chickens. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunette, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. For increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens.
ORAL—The NADA provides for the use of approved, single-ingredient Type A medicated articles containing diclazuril and roxarsone to formulate two-way combination drug Type C medicated feeds for broiler chickens.
Federal Register 03/03/04

Elanco Animal Health
(NADA 141-224)
Ractopamine Hydrochloride plus Monensin Sodium plus Tylosin Phosphate
(Optaflexx plus Rumensin plus Tylan)
Cattle. Increased rate of weight gain, improved feed efficiency, and increased carcass leanness; for prevention and control of coccidiosis due to E. bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
ORAL—The NADA provides for use of ractopamine, monensin and tylosin phosphate Type A medicated articles to make dry and liquid three-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.
Federal Register 03/15/04

Elanco Animal Health
(NADA 141-225)
Ractopamine Hydrochloride plus Monensin Sodium
(Optaflexx plus Rumensin)
Cattle. For increased rate of weight gain, improved feed efficiency and increased carcass leanness; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
ORAL—NADA provides for use of ractopamine and monensin Type A medicated articles to make dry and liquid two-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.
Federal Register 03/15/04

Merial Ltd.
(NADA 141-227)
Omeprazole Paste (Ulcergard)
Cattle. For increased rate of weight gain, improved feed efficiency and increased carcass leanness; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
ORAL—NADA provides for use of ractopamine and monensin Type A medicated articles to make dry and liquid two-way combination Type B and Type C medicated feeds for cattle fed in confinement for slaughter.
Federal Register 03/15/04

Phibro Animal Health
(NADA 141-226)
Semduramicin Sodium plus Virginiamycin plus Roxarsone
(Aviax plus Stafac plus 3-Nitro)
Broiler chickens. Used for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. necatrix and E. tenella; for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for increased rate of weight gain, improved feed efficiency and improved pigmentation in broiler chickens.
ORAL—The NADA provides for the use of approved, single-ingredient Type A medicated articles containing semduramicin, virginiamycin and roxarsone to formulate three-way combination drug Type C medicated feeds for broiler chickens.
Federal Register 03/22/04