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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - September/October 2002

FDA Veterinarian Newsletter 2002 Volume XVI, No V

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Alpharma, Inc.
(NADA 48-761)
Chlortetracycline (Aureomycin 50, 90, 100)
Calves, beef, non-lactating dairy cattle. For the treatment of enteritis and pneumonia.
MEDICATED FEED-The supplemental NADA provides for the administration of Type C medicated feeds containing chlortetracycline to cattle as a top dress to deliver 10 milligrams chlortetracycline per pound of body weight daily. These medicated feeds are used for the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
Federal Register 06/27/02

Pharmacia and Upjohn Co.
(NADA 140-890)
Ceftiofur Hydrochloride (Excenel® RTU Sterile Suspension) RX
Cattle. For the treatment of acute metritis.
INTRAMUSCULAR OR SUBCUTANEOUS-The supplemental NADA provides for injection of ceftiofur hydrochloride in cattle for the treatment of acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Federal Register 07/11/02

Intervet, Inc.
(NADA 121-473)
Fenbendazole (Panacur®)
Dogs. For removal of certain internal parasites.
ORAL-The supplemental NADA allows a change from prescription to over-the-counter marketing status of fenbendazole granules for oral use in dogs.
Federal Register 07/19/02

Elanco Animal Health
Division of Eli Lilly & Co.
(NADA 140-863)
Ractopamine (Paylean®)
Swine. For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine fed a complete ration containing at least 16 percent crude protein.
MEDICATED FEED-The first supplemental NADA provides for using ractopamine, a Type A medicated article, used to make Type B and Type C medicated feeds for finishing swine, in a 45-g/lb strength of Paylean and for amending the assay limits for Type B and Type C medicated feeds containing ractopamine. The second supplemental NADA provides for the addition of cautionary statements to labeling.
Federal Register 07/22/02

Pharmacia and Upjohn Co.
Pair 1 - (NADA 124-309 and NADA 125-476)
Pair 2 - (NADA 138-792 and NADA 138-870)
Pair 3 - (NADA 138-995 and NADA 139-192)
Melengestrol acetate (MGA®)
Monensin sodium (Rumensin®)
Tylosin phosphate (Tylan®)
Feedlot heifers.
Pair 1 for increased rate of weight gain, improved feed efficiency, and suppression of estrus. (MGA & Rumensin)
Pair 2 all indications for pair 1 and 3 plus the prevention and control of coccidiosis due to Eimeria bovis and E. Zuernii. (MGA & Rumensin (50 to 360 mg/head/day) & Tylan)
Pair 3 to reduce liver abscesses caused by Fusobacterium necrophorum and Actinomyces pyogenes. (MGA & Tylan extended to 60 to 90 mg/head/day)
MEDICATED FEED-The 6 supplemental NADA's provide for the use of single-ingredient Type A medicated articles containing melengestrol acetate, monensin, and tylosin to make two-way and (with tylosin) three-way, dry and liquid, combination drug Type C medicated feeds for heifers fed in confinement for slaughter. Some of the supplemental NADA's add the single-ingredient monensin claim for prevention and control of coccidiosis in feedlot heifers to the indications for combinations of melengestrol acetate and monensin with and without tylosin. Other supplemental NADA's extend the dose of tylosin to the single-ingredient range of 60 to 90 mg per head per day to reduce the incidence of liver abscesses in feedlot heifers and provide for use of liquid Type C medicated feeds containing melengestrol acetate and tylosin with and without monensin.
Federal Register 07/22/02

Phibro Animal Health, Inc.
(NADA 8-804)
(NADA 95-143)
Oxytetracycline (TM-50, TM-50D, TM-100, TM-100D, OXTC)
Swine. For treatment of various bacterial diseases.
MEDICATED FEED: The two supplemental NADA's provide for use of oxytetracyclineType A medicated articles used for making Type C medicated feeds. The supplemental NADA's provide for a zero-day withdrawal time prior to slaughter when Type C medicated feeds containing oxytetracycline are fed continuously at a dosage of 10 mg/lb of body weight for up to 14 days.
Federal Register 08/07/02