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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - March/April 1999

FDA Veterinarian Newsletter March/April 1999 Volume XIV, No II

CompanyGeneric and Brand NamesIndicationsRoutes/Remarks
Pfizer, Inc.
(NADA 141-061)
Doramectin (Dectomax®)Cattle. For added subcutaneous and intramuscular use to control infections and to protect from reinfection with C. oncophora for 14 days and O. radiatum for 28 days after treatment.SUBCUTANEOUS AND INTRAMUSCULAR: The supplement provides a new persistent use which is in addition to the currently approved use in cattle for treatment and control of various gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice and mangemites, and to control infections and to protect from reinfection with O. osteragi for 21 days and C. punctata and D.viviparus for 28 days. In addition, a tolerance for doramectin and its residues in cattle muscle is established and an ADI is codified. Federal Register: 12/10/98.

Pfizer, Inc.

(NADA 141-095)

Doramectin (Dectomax®) Beef and Non-lactating Dairy Cattle. To treat and control horn flies in addition to its use for treatment and control of strointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, and mange mites, and to control infections and to protect from reinfection with C. oncophora and D. viviparus for 21 days, O. osteragi, C. punctata, and O. radiatum, for 28 days after treatment.TOPICAL: The supplement adds the hornfly treatment to the already approved uses. In addition, a tolerance for doramectin and its residues in cattle is established and an ADI is codified. Federal Register: 12/10/98.
Merial Ltd.
(NADA 200-147)
Gentamicin Sulfate Injection (Genta-Ject®) Turkey poults. For prevention of early mortality due to susceptible Arizona paracolon infections.SUBCUTANEOUS: The supplement provides for injection in the necks of 1 to 3 day old turkey poults. Federal Register: 12/10/98.
Pfizer, Inc.
(NADA 110-048)
Albendazole Suspension (Valbazen®) Sheep. For use of the 11.36% suspension in sheep as well as cattle as an anthelmintic.ORAL: The supplement adds sheep to the already approved use in cattle. In addition a tolerance for residues of albendazole in muscle of cattle and sheep is established and an ADI is codified. Federal Register: 1/11/99.
Pfizer, Inc.
(NADA 141-080)
Selegiline Hydrochloride (Anipryl®) RxDogs. For the control of clinical signs associated with canine cognitive dysfunction syndrome.ORAL: The supplement adds the control of canine cognitive dysfunction syndrome to the already approved use for control of clinical signs of uncomplicated pituitary-dependent hyperadrenocorticism. This approval qualifies for 3 years of marketing exclusivity beginning on December 10, 1998. Federal Register:01/13/99.
Elanco Animal Health, Division of Eli Lilly and Co. (NADA 104-646)Monensin (Rumensin® ) /Tylosin (Tylan ®)Cattle. For improved feed efficiency and the reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces pyogenes.MEDICATED FEED: The supplement changes the feeding of the Tylosin portion of the Type C medicated feed from 90 mg/hd/day to 60 to 90 mg/hd/day. Federal Register: 01/19/99.
Elanco Animal Health Division of Eli Lilly & Co.
(NADA 95-735)
Monensin (Rumensin®) Cattle. For feedlot cattle and non-veal calves for prevention and control of coccidiosis; for pasture cattle for increased rate of weight gain, for mature reproducing beef cattle for improved feed efficiency.MEDICATED FEED: The supplement provides for revised feeding directions of the Type B and C medicated cattle feeds, added uses of monensin Type C medicated feeds for prevention and control of coccidiosis, and to amend the residue tolerances for monensin residues. Federal Register: 02/03/99.
Alpharma, Inc. (NADA 116-088)Bacitracin Methylene Disalicylate (BMD® ), Monensin(Coban® ), and Roxarsone (3-Nitro® )Broiler chickens. Used as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylene disalicylate; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of weight gain and improved feed efficiency.MEDICATED FEED: The supplement adds an additional use level of BMD®/ Monensin/Roxarsone Type C medicated broiler chicken feeds. Federal Register: 02/04/99.
Schering-Plough Animal Health Corp.
(NADA 141-063)
Florfenicol (Nuflor®) RxCattle. For control of respiratory disease in cattle at high risk of developing bovine respiratory disease (BRD).SUBCUTANEOUS: The supplement provides for a single injection for control of respiratory disease in cattle at high risk of developing BRD associated with Pasteurella haemolytica, P. multocida, andHaemophilus somnus. This supplemental approval qualifies for 3 years of marketing exclusivity beginning December 17, 1998. Federal Register: (02/04/99).