The complete handbook of approved new animal drugs in the united states

CHAPTER FIVE
APPROVED NEW ANIMAL DRUGS BY NADA NUMBER
BRAND NAME
SPONSOR FIRM
APPROVAL DATE
TETRAMED 324 HCA
CROSS VETPHARM GROUP LTD.
09/13/2005
INGREDIENT(S) : TETRACYCLINE HYDROCHLORIDE BEEF CATTLE DAIRY CATTLE SWINE CHICKEN TURKEY: Calves and Swine: Control/treatment of
bacterial enteritis caused by E. coli; bacterial pneumonia associated with susceptible Pasteurella,
Hemophilus, and Klebsiella spp. Chicken: Control of chronic respiratory disease and air sac infection;
infectious synovitis susceptible to tetracycline. Turkey: Control of infectious synovitis and bluecomb
(transmissible enteritis, coronaviral enteritis) caused by complicating bacterial organisms susceptible to
tetracycline.
Each lb. contains 324 g tetracycline hydrochloride. Beef Cattle Dairy Cattle Swine: Add to drinking
water to provide 10 mg/lb. BWT/day/3-5 days. Chicken Turkey: Administer in drinking water to provide
25 mg/lb. BWT/day. Do not administer more than 14 consecutive days; not for use in chickens or turkeys
producing eggs for human consumption; prepare a fresh solution daily. Use as sole source of tetracycline
for all above species. A withdrawal period has not been established for this product in preruminating
calves. Do not use in calves to be processed for veal.
21CFR556.720: Ctl, Ckn, Trk, Swn: 2.0 ppm M, 6.0 ppm L, 12 ppm F & K.
HEIFERMAX+RUMENSIN+TYLA
IVY LABORATORIES, DIV. OF IVY A.H., INC.
09/19/2005
INGREDIENT(S) : MELENGESTROL ACETATE, MONENSIN SODIUM, TYLOSIN TARTRATE BEEF CATTLE: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and reduced incidence of liver abscesses in heifers being fed in confinement for slaughter.
Provides for use of dry Type A MGA medicated articles containing 100 or 200 mg/lb. or liquid Type A article containing 500 mg/lb. in combination with Type A medicated articles containing monensin sodium and tylosin tartrate. Administer MGA at the rate of 0.25 to 0.50 mg/head/day, plus monensin (as monensin sodium) at 50 to 360 mg/head/day, plus tylosin (as tylosin tartrate) at 90 mg/head/day. These dosages may be attained by adding 0.5 to 2.0 lbs/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg MGA/lb. to a medicated feed containing 5 to 30 g monensin and 8 to 10 g tylosin/ton; or; by adding 0.5 to 2.0 lbs./head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg MGA plus 25 to 720 mg monensin/lb. to 4.5 to 18 lbs. of a dry medicated feed containing 10 to 40 g tylosin/ton; or; by adding 0.5 to 2.0 lbs./head/day of a dry pelleted medicated feed containing 0.125 to 1.0 mg of MGA (from a dry Type A article), 25 to 600 mg monensin, plus 45 to 180 mg tylosin/lb. to a ration of non-medicated feed. 21CFR: MGA: 556.380: Zero T; Tyl: 556.740: 0.2 ppm F, M, L, K; Mon: 556.420: 25 ppb T.
SULFAMED-G SOLUBLE
CROSS VETPHARM GROUP LTD.
11/14/2005
COPYRIGHT 2006 SHOTWELL & CARR, INC.
PAGE 5. 547
CHAPTER FIVE
APPROVED NEW ANIMAL DRUGS BY NADA NUMBER
BRAND NAME
SPONSOR FIRM
APPROVAL DATE
BEEF CATTLE DAIRY CATTLE CHICKEN TURKEY: Cattle: For treatment of shipping fever
complex, calf diphtheria, bacterial pneumonia and foot rot; Chicken Turkey: Treatment of coccidiosis,
fowl cholera and in chickens for treatment of infectious coryza.
Each packet of powder contains the equivalent of 94.6 g sulfadimethoxine (as the sodium salt). Cattle: Administer 2.5 g/100 lbs. BWT first day, 1.25 g/100 lbs. BWT for the next 4 days in drinking water or drench. Chickens: add to drinking water at 1.875 g/gallon for 6 days. Not for chickens over 16 weeks of age. Turkeys, add to drinking water at 0.938 g/gallon for 6 days. For meat- producing turkeys only. Not for turkeys over 24 weeks of age. Federal law prohibits the extralabel use of this product in lactating dairy cattle. WITHDRAWAL : Poultry: 5 days; Cattle: 7 days.
21CFR556.640: Ckn Trk Ctl: 0.1 ppm T, 0.01 ppm Milk.
LINCOMED SOLUBLE POWDER
CROSS VETPHARM GROUP LTD.
12/06/2004
SWINE CHICKEN: Swine: For the treatment of swine dysentery (bloody scours). Chicken: For control
of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.
Packets contain the equivalent of either 16 or 32 g lincomycin. Swine: Add to drinking water at a level of
250 mg/gallon to provide 3.8 mg/lb. BWT/day. Do not use for more than 10 days. The safety of
lincomycin has not been demonstrated for pregnant swine or swine intended for breeding. Chicken: Add
to drinking water at a rate of 64 mg/gallon. Administer for 7 consecutive days. Not for use in layer and
breeder chickens. Both species: Discard medicated solutions if not used within 2 days. Prepare fresh
stock solutions daily.
21CFR556.360: ADI for total residues of lincomycin is 25 mcg/kg BWT. Swine: 0.6 ppm L, 0.1 ppm M.
SPECLINX-50 WATER SOLUBLE
CROSS VETPHARM GROUP LTD.
06/07/2005
INGREDIENT(S) : LINCOMYCIN HYDROCHLORIDE, SPECTINOMYCIN DIHYDROCHLORIDE CHICKEN: As an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum and complicated chronic respiratory disease caused by Escherichia coli and M. gallisepticum. Administer in the drinking water at 2 g antibiotic activity/gallon as the sole source of water for the first 5-7 days of life. COPYRIGHT 2006 SHOTWELL & CARR, INC.
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CHAPTER FIVE
APPROVED NEW ANIMAL DRUGS BY NADA NUMBER
BRAND NAME
SPONSOR FIRM
APPROVAL DATE
21CFR: Lin: 556.360: 0.1 ppm T; Spe: 556.600: 0.1 ppm T.
FUROSEMIDE SYRUP 1%
PHOENIX SCIENTIFIC, INC.
11/18/2004
INGREDIENT(S) : FUROSEMIDE DIETHANOLAMINE DOG: For treatment of edema associated with cardiac insufficiency and acute noninflammatory tissue edema. Give 10-20 mg/10 lbs. BWT once or twice/day, with a 6-8 hour interval between doses. Adjust dose to animal's response. If given in excessive amounts or over an extended period of time, dehydration and/or electrolyte imbalance may result. LEVAMISOLE HCL SOLUBLE
PHOENIX SCIENTIFIC, INC.
12/17/2004
DRENCH POWDER
BEEF CATTLE DAIRY CATTLE SHEEP: For use as an anthelmintic against stomach worms, intestinal worms and lungworms. Dissolve contents of package in water to provide 32 fl. oz. of drench solution and administer as a drench at 0.25 oz./100 lbs. BWT (8 mg/kg BWT) in a single dose, or dissolve in water to provide 8.75 fl. oz. of concentrate and administer as a drench at the rate of 2 mL/100 lbs. BWT as a single oral dose by syringe. May re-treat in 2-4 weeks. Do not use in dairy animals of breeding age. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult veterinarian before using in severely debilitated animals.
WITHDRAWAL : Cattle: 48 hours. Sheep: 72 hours.
FLUNIXIN INJECTABLE
CROSS VETPHARM GROUP LTD.
03/02/2006
SOLUTION
BEEF CATTLE DAIRY CATTLE HORSE: Horse: For alleviation of pain and inflammation associated
with musculoskeletal disorders and for alleviation of visceral pain associated with colic. Cattle: For
control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also
indicated for control of inflammation in endotoxemia.
COPYRIGHT 2006 SHOTWELL & CARR, INC.
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CHAPTER FIVE
APPROVED NEW ANIMAL DRUGS BY NADA NUMBER
BRAND NAME
SPONSOR FIRM
APPROVAL DATE
Horses: Give 0.5 mg/lb. BWT/day. For musculoskeletal disorders give IM or IV for up to 5 days. For
colic use single dose IV. Single dose may be repeated if indicated. The effect of this drug on pregnancy
has not been determined. Cattle: Administer 1.1 to 2.2 mg/kg BWT (0.5 to 1 mg per lb., 1 to 2 mL per 100
pounds), once a day as a single dose or divided into 2 doses administered at 12-hour intervals for up to 3
days. Do not slaughter for food use within 4 days of last treatment. Not for use in dry dairy cows. A
withdrawal period has not been established for use in preruminating calves. Do not use in calves to be
processed for veal. Do not use in bulls intended for breeding as reproductive effects in bulls have not been
studied. Not for use in horses intended for food.
WITHDRAWAL : Cattle: 4 days; 36 hour milk discard. Not for use in horses intended for food.
21CFR556.286: 0.125 ppm liver; 0.025 ppm muscle; 0.02 ppm milk. ADI is 0.72 mcg/kg/BWT/day.
IVERMECTIN PASTE 1.87%
MED-PHARMEX, INC.
06/20/2006
HORSE: For treatment and control of large strongyles (adults) (Strongylus vulgaris (also early forms in
blood vessels), S. edentatus (also tissue stages), S. equinus; Triodontophorus spp.; including T. brevicauda
and T. serratus; and Craterostomum acuticaudatum); small strongyles including those resistant to some
benzimidazole class compounds (adults and fourth-stage larvae) (Coronocyclus spp., including C.
coronatus, C. labiatus, and C. labratus; Cyathostomum spp., including C. catinatum and C. pateratum;
Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus;
Cylicodontophorus spp.; Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C.
minutus; and Petrovinema poculatum); pinworms (adults and fourth stage larvae) (Oxyuris equi); ascarids
(adults and third- and fourth-stage larvae) (Parascaris equorum); hairworms (adults) (Trichostrongylus
axei); large-mouth stomach worms (adults) (Habronema muscae); bots (oral and gastric stages)
(Gasterophilus spp., including G. intestinalis and G. nasalis); lungworms (adults and fourth-stage larvae)
(Dictyocaulus arnfieldi); intestinal threadworms (adults) (Strongyloides westeri); summer sores caused by
Habronema and Draschia spp. cutaneous third-stage larvae; and dermatitis caused by neck threadworm
microfilariae, Onchocerca sp.
WITHDRAWAL : Not for use in horses intended for food.
GRISEOFULVIN POWDER
PHOENIX SCIENTIFIC, INC.
06/01/2006
MICROSIZE
HORSE: For treatment of ringworm infection caused by Trichophyton equinum and Microsporum gypseum. Administer orally on the basis of age as follows: Adults: 1 packet (2.5 g)/day; Yearlings: 0.5-1 packet (1.25-2.5 g)/ day; Foals: 0.5 packet (1.25 g)/day. Continue treatment for not less than 10 days. COPYRIGHT 2006 SHOTWELL & CARR, INC.
PAGE 5. 550
CHAPTER FIVE
APPROVED NEW ANIMAL DRUGS BY NADA NUMBER
BRAND NAME
SPONSOR FIRM
APPROVAL DATE
WITHDRAWAL : Not for use in horses intended for food.
HEIFERMAX 500 LIQUID
IVY LABORATORIES, DIV. OF IVY A.H., INC.
03/22/2006
PREMIX+RUMENSIN TYPE A
BEEF CATTLE: For increased rate of weight gain, improved feed efficiency, suppression of estrus, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in heifers being fed in confinement for slaughter.
Provides for dry Type A medicated articles containing 100 or 200 mg MGA/lb. or liquid Type A article containing 500 mg/lb. to deliver 0.25 to 0.40 mg MGA/head/day, plus monensin (as monensin sodium), 50 to 360 mg/head/day. Add at the rate of 0.5 to 2.0 lbs./head/day a medicated feed (liquid or dry) containing 0.125 to 0.80 mg MGA/lb. to a feed containing 5 to 30 g monensin/ton; or, add at the rate of 0.5 to 2.0 lbs./head/day a medicated feed (liquid or dry) containing 0.125 to 0.80 mg MGA plus 25 to 720 mg monensin/lb. to a non-medicated feed to provide 0.25 to 0.40 mg MGA and 50 to 360 mg monensin/head/day. 21CFR MGA: 556.380: 25 ppb T; Mon: 556.420: 0.05 ppm T. ADI for monensin: 12.5 mcg/kg BWT/day.
HEIFERMAX+ OPTAFLEXX+
IVY LABORATORIES, DIV. OF IVY A.H., INC.
04/27/2006
RUMENSIN+ TYLAN
INGREDIENT(S) : MELENGESTEROL ACETATE, RACTOPAMINE HYDROCHLORIDE, MONENSIN SODIUM, BEEF CATTLE: For increased rate of weight gain, improved feed efficiency, increased carcass leaness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and for suppression of estrus (heat), and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Provides for the use of Type A articles to make four-way combination Type C medicated feeds. Administer 9.8 to 24.6 g/ton ractopamine, 10 to 30 g/ton monensin, 8 to 10 g/ton tylosin and 0.25 to 0.5 mg/head/day melengesterol acetate. 21CFR558.342, .355, .500, & .625. Sp# 21641.
21CFR556: ractopamine: .570; monensin: .420; MGA: .380; tylosin: .740.
COPYRIGHT 2006 SHOTWELL & CARR, INC.
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CHAPTER FIVE
APPROVED NEW ANIMAL DRUGS BY NADA NUMBER
BRAND NAME
SPONSOR FIRM
APPROVAL DATE
HEIFERMAX 500 LIQUID
IVY LABORATORIES, DIV. OF IVY A.H., INC.
04/19/2006
PREMIX AND TYLAN
INGREDIENT(S) : MELENGESTROL ACETATE, TYLOSIN PHOSPHATE BEEF CATTLE: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers being fed in confinement for slaughter. Provides for the use of liquid Type A medicated article containing 500 mg MGA/lb. Administer 0.25 to 0.50 mg MGA with 90 mg tylosin/head/day. These dosages may be attained by adding 0.5 to 2.0 lbs./head/day of a liquid dry medicated feed containing 0.125 to 1.0 mg MGA/lb. to a medicated feed containing 8 to 10 g tylosin/ton; or by adding 0.5 to 2.0 lbs./head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg MGA/lb. to 4.5 to 18 lbs. dry medicated feed containing 10 to 40 g tylosin/ton. 21CFR: MGA: 556.380: 25 ppb F; Tylosin: 556.740: 0.2 ppm F, M, L, K.
COPYRIGHT 2006 SHOTWELL & CARR, INC.
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