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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 2003

FDA Veterinarian Newsletter May/June 2003 Volume XVIII, No 3

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Alpharma, Inc.
(NADA 107-996)
Lasalocid (Avatec), Bacitracin Methylene Disalicylate (BMD)
Chickens. For the prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency.
MEDICATED FEED—The supplemental NADA provides for a zero-day withdrawal period for the use of approved two-way combination drug Type C medicated feeds containing lasalocid and bacitracin methylene disalicylate in broiler and fryer chickens.
Federal Register 03/31/03

Schering-Plough Animal Health Corp.
(NADA 141-177)
Gentamicin sulfate, Mometasone furoate, Clotrimazole
(MometamaxTM) RX
Dogs. For treatment of otitis externa.
OTIC—The supplemental NADA provides for the addition of once-daily administration to the dosage regimens for gentamicin/mometasone/clotrimazole otic suspension used to treat otitis externa in dogs.
Federal Register 03/31/03

Novartis Animal Health, Inc.
(NADA 141-203)
Deracoxib (DeramaxxTM) RX
Dogs. For the control of pain and inflammation.
ORAL—The supplement provides for veterinary prescription use of deracoxib chewable tablets for the control of pain and inflammation associated with osteoarthritis.
Federal Register 04/17/03