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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVALS - November/December 1999

FDA Veterinarian Newsletter November/December 1999 Volume XIV, No VI

CompanyGeneric and Brand NamesIndicationsRoutes/Remarks
Pfizer, Inc.
(NADA 141-114)
Semduramicin (Aviax®) and Virginiamycin (Stafac®)Broiler chickens. For the prevention of coccidiosis and for increased rate of weight gain (22.7 g/t semduramicin and 5 to 15 g/t virginiamycin). For the prevention of coccidiosis and for increased rate of weight gain and improved feed efficiency (22.7 g/t and 5 g/t). For the prevention of coccidiosis and of necrotic enteritis (22.7 g/t and 20 g/t).MEDICATED FEED: The NADA provides for using approved single ingredient semduramicin and virginiamycin Type A medicated articles to make a combination drug Type C medicated broiler chicken feed. Feed continuously as sole ration. The NADA also provides for tolerances for semduramicin residues and an acceptable daily intake(ADI) for semduramicin and for virginiamycin. Federal Register: 09/03/99
Hoechst Roussel Vet
(NADA 141-129)
Lasalocid (Avatec®) and Bambermycins (Flavomycin®)Broiler chickens. For the prevention of coccidiosis and for increased rate of weight gain and improved feed efficiency.MEDICATED FEED: The NADA provides for combining approved single ingredient lasalocid and bambermycins Type A medicated articles to make Type C medicated broiler feeds. Feed continuously as the sole ration. Federal Register: 09/10/99
Hoechst Roussel Vet
(NADA 140-339)
Nicarbazin (Nicarb®) and Bambermycins (Flavomycin®)Broiler chickens. For use as an aid in preventing outbreaks of cecal and intestinal forms of coccidiosis, and for increased rate of weight gain and improved feed efficiency.MEDICATED FEED: The NADA provides for combining approved single ingredient nicarbazin and bambermycins Type A medicated articles to make Type C medicated broiler chicken feeds. Feed continuously as the sole ration. Nicarbazin is a Category II drug, and use of Type A medicated articles to make Type C medicated feeds is limited to manufacture in a licensed feed mill. Federal Register: 09/13/99
Roche Vitamins, Inc.
(NADA 141-150)
Lasalocid (Avatec®) and Virginiamycin (Stafac®)Turkeys. For prevention of coccidiosis and for increased rate of weight gain and improved feed efficiency in growing turkeys.MEDICATED FEED: The NADA provides for combining Type A medicated articles to make Type C medicated feeds. Feed continuously as the sole ration. Federal Register: 09/14/99