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U.S. Department of Health and Human Services

Animal & Veterinary

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New Animal Drug Approvals - November/December 2003

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

Company
Generic and (Brand) Names
Indications
Routes/Remarks 

Fort Dodge Animal Health
Division of Wyeth
(NADA 141-216)
Moxidectin/Praziquantel (Quest® Plus)
Horses and ponies. For treatment and control of various species of internal parasites.
ORAL-The NADA provides for use of a moxidectin and praziquantel oral gel for the treatment of various species of internal parasites in horses and ponies.
Federal Register 08/27/03

Novartis Animal Health US, Inc.
(NADA 141-204)
(NADA 141-205)
(NADA 141-035)
(NADA 141-084)
(NADA 141-175)
Lufenuron (Program)
Milbemycin Oxime and Lufenuron (Sentinel®), Nitenpyram (Capstar®) RX for concurrent use
Dogs and Cats. To kill adult fleas and prevent flea eggs from hatching.
ORAL-An original NADA was filed, 141-204, for the concurrent use in dogs of Sentinel tablets (milbemycin oxime and lufenuron), approved under NADA 141-084, with Capstar tablets (nitenpyram), approved under NADA 141-175, to kill adult fleas and prevent flea eggs from hatching. Another original NADA, 141-205, was also filed for the concurrent use in dogs and cats of Program (lufenuron) Flavor Tabs, approved under NADA 141-035, with Capstar tablets (nitenpyram) to kill adult fleas and prevent flea eggs from hatching. Supplemental NADA's to NADA 141-035, NADA 141-084, and NADA 141-175 were also filed to provide appropriate labeling for the concurrent uses of these products under NADA 141-204 and NADA 141-205, and to NADA 141-035 for use of lufenuron flavor tablets in puppies and kittens as young as four weeks of age.
Federal Register 08/29/03

Elanco Animal Health
A Division of Eli Lilly & Co.
(NADA141-221)
Ractopamine hydrochloride (Optaflexx™ 45)
Cattle. For increased rate of weight gain, improved feed efficiency, and carcass leanness.
MEDICATED FEED-The NADA provides for use of ractopamine hydrochloride Type A medicated articles to make Type B and Type C medicated feeds in cattle fed in confinement for slaughter.
Federal Register 09/18/03

Norbrook Labotatories, Ltd.
(NADA 141-143)
Oxytetracycline (Tetradure 300) RX
Cattle, Swine. For treatment of various bacterial diseases and for the control of respiratory disease.
SUBCUTANEOUS OR INTRAMUSCULAR-The NADA provides for veterinary prescription use of Tetradure 300 Injection and over-the-counter use of Oxytetracycline Injection 300mg/ml for the treatment of various bacterial diseases of cattle and swine. Norbrook Laboratories' Tetradure 300 Injection and Oxytetracycline Injection 300mg/ml are approved as generic copies of Pfizer's Liquamycin LA-200, approved under NADA 113-232. Tetradure 300 Injection is also indicated for the control of respiratory diseases in cattle at high risk of developing BRD associated with Manheimia haemolytica.
Federal Register 09/19/03

Novartis Animal Health US, Inc.
(NADA 141-218)
Cyclosporine (Atopica) RX
Dogs. For the control of atopic dermatitis.
ORAL-The NADA provides for the veterinary prescription use of Atopica for the control of atopic dermatitis in dogs weighing at least 4 pounds body weight.
Federal Register 09/19/03

Virbac AH, Inc.
(NADA 141-215)
Ivermectin/Praziquantel (Equimax™)
Horses. For the treatment and control of various species of internal parasites.
ORAL-The NADA provides for use of an EQUIMAX paste in horses.
Federal Register 09/25/03