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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL ABBREVIATED NEW ANIMAL DRUG APPROVALS - November/December 1999

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

CompanyGeneric and Brand NamesIndicationsRoutes/Remarks
Roche Vitamins, Inc.
(NADA 40-209)
Sulfadimethoxine and Ormetoprim (Rofenaid®)Ducks. For the control of bacterial infections.MEDICATED FEED: The supplement provides for changing the name of a pathogen from Pasteurella anatipestifer to Riemerella anatipestifer. Federal Register: 08/12/99
Schering-Plough Animal Health Corp.
(NADA 38-233)
Zeranol (Ralgro® Magnum)Beef Steers. For improved feed efficiency.SUBCUTANEOUS: The supplement provides for use of the implant in steers fed in confinement for slaughter for improved feed efficiency. Three year marketing exclusivity is granted. Federal Register: 08/27/99
Ivy Laboratories, Div. of Ivy Animal Health, Inc.
(NADA 110-315)
Progesterone, Estradiol benzoate, and Tylosin tartrate (Component® E-S with Tylan® 200mg/20mg/29mg) and (Component® E-C with Tylan® (100mg/10mg/29mg)Beef Steers over 400 lb. and Suckling Beef Calves up to 400 lb. For increased rate of weight gain and/or improved feed efficiency.SUBCUTANEOUS: The supplement provides for addition of a tylosin pellet to the implant as a local antibacterial. Three years of marketing exclusivity is granted. Federal Register: 09/03/99
Ivy Laboratories, Div. of Ivy Animal Health, Inc.
(NADA 135-906)
Testosterone propionate Estradiol benzoateTylosin tartrate (Component® E-H with Tylan® 200mg/20mg/29mg)Beef Heifers weighing over 400 lbs. For growth promotion and improved feed efficiency.SUBCUTANEOUS: The supplement provides for addition of a tylosin pellet to the implant as a local antibacterial. Three years of marketing exclusivity is granted. Federal Register: 09/03/99
Bayer Corp., Agriculture Division, Animal Health
(NADA 140-441)
Enrofloxacin (Baytril®Rx)Dogs and Cats. For the management of diseases associated with bacteria susceptible to enrofloxacin.ORAL: The supplement provides for an additional tablet size and for the removal of a tablet size no longer marketed. Federal Register: 09/03/99
Intervet, Inc.
(NADA 140-927)
Chorionic Gonadotropin (Chorulon® freeze-dried powder)Male and Female brood finfish. As an aid in improving spawning function.INTRAMUSCULAR: The supplement provides for injection of reconstituted chorionic gonadotropin in finfish. An ADI for total gonadotropins is provided for and a tolerance for residues in edible tissue of treated animals is deemed not required. Federal Register: 09/07/99
Pfizer, Inc.
(NADA 141-152)
Selamectin (Revolution) RxDogs. For control of tick infestations.TOPICAL: The supplement provides for the additional indication of control of tick (Dermacentor variabilis) infestations. This approval qualifies for 3 years of marketing exclusivity. Federal Register: 09/08/99
Pfizer, Inc.
(NADA 141-095)
Doramectin (Dectomax®)Cattle. For treatment and control of the gastrointestinal roundworm Trichostrongylus axei L4 and for control of and protection from reinfection with Haemonchus placei for 35 days after treatment.TOPICAL: The supplement broadens the use of doramectin to include control of certain roundworms and control and protection from reinfection with Haemonchus placei for 35 days after treatment. Federal Register: 09/10/99
Pfizer, Inc.
(NADA 140-819)
Pyrantel Tartrate (Strongid®)Horses. For the prevention of Strongylus vulgaris larval infection and control of several types of adult and 4th stage larval large and small strongyle, pinworm, and ascarid infections.MEDICATED FEED: The supplement provides for revised feeding instructions for use of pyrantel tartrate Type A medicated articles to make Type C medicated horse feeds. Federal Register: 10/05/99