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U.S. Department of Health and Human Services

Animal & Veterinary

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Supplemental New Animal Drug Approvals - November/December 2003

FDA Veterinarian Newsletter November/December 2003 Volume XVIII, No 6

Generic and (Brand) Names

Fort Dodge Animal Health
Division of Wyeth
(NADA 141-087)
Moxidectin (Quest™ 2.0% Equine Oral gel)
Horses and ponies. For the control of various internal parasites.
ORAL-The supplemental NADA adds an age precaution to labeling for moxidectin gel used for control of various species of internal parasites for oral use in horses and ponies 6 months of age and older.
Federal Register 08/27/03

Fort Dodge Animal Health
Division of American Cyanamid Co.
(NADA 141-108)
Etodolac (Etogesic™) RX
Dogs. For the management of pain and inflammation associated with osteoarthritis.
ORAL-The supplemental NADA provides for a 500-mg tablet size of Etodolac.
Federal Register 08/28/03

Pharmacia & Upjohn Co.
(NADA 141-200)
Progesterone (Eazi-BreedTM CIDR®)
Dairy cows. For synchronization of the return to estrus.
INTRAVAGINAL-The supplemental NADA provides for use of progesterone intravaginal inserts in lactating dairy cows inseminated at the immediately preceding estrus.
Federal Register 10/06/03