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U.S. Department of Health and Human Services

Animal & Veterinary

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Supplemental 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

Fort Dodge Animal Health, Division of Wyeth
(NADA 141-216)
Moxidectin plus Praziquantel Gel (Quest Plus)
Horses and ponies. For the treatment and control of various species of internal parasites in horses and ponies.
ORAL—The supplemental NADA provides for the speciation of adult small strongyles in product labeling.
Federal Register 04/23/04

Pharmacia & Upjohn Co.
(NADA 140-338)
Ceftiofur Sodium Sterile Powder for Injection (Naxcel)
Horses. For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
INTRAMUSCULAR OR SUBCUTANEOUS—The supplemental NADA provides updated susceptibility data for equine respiratory pathogens listed in the clinical microbiology section of labeling and added the National Committee for Clinical Laboratory Standards’ interpretive criteria for equine isolates.
Federal Register 04/15/04

Schering-Plough Animal Health Corp.
(NADA 112-051)
Levamisole hydrochloride (Levasole Soluble Drench Powder)
Cattle and sheep. A broad spectrum anthelmintic and is effective against various adult nematode infections.
ORAL—The supplemental NADA revises the description of various internal parasites in labeling for levamisole powder used to make a drench solution for oral administration.
Federal Register 03/02/04