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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
decoquinate
039-417
Deccox
decoquinate
141-060
Deccox® -M Medicated Powder for
Whole Milk
Decoquinate
Decoquinate Bacitracin methylene disalicylate
141-102
DECCOX®, BMD®;
Decoquinate Bacitracin methylene disalicylate
Decoquinate, bacitracin methylene disalicylate, roxarsone
141-100
DECCOX®,BMD®, 3-NITRO®
Decoquinate, bacitracin methylene disalicylate, roxarsone
decoquinate, bacitracin zinc
200-213
Deccox®, Albac®
decoquinate, bacitracin zinc
decoquinate, bacitracin zinc, roxarsone
200-206
Deccox®; Albac®; 3-Nitro®
decoquinate, bacitracin zinc, roxarsone
Decoquinate, chlortetracycline
141-147
Deccox® plus Chloromax®
Decoquinate, chlortetracycline
141-185
Deccox® plus Aureomycin®
decoquinate, chlortetracycline
decoquinate, monensin
141-148
DECCOX® RUMENSIN®
decoquinate, monensin
decoquinate, monensin, tylosin
141-149
Deccox® Rumensin® Tylan®
decoquinate, monensin, tylosin
decoquinate, Type A medicated article.
039-417
Deccox;
decoquinate, Type A medicated article.

                                                                   
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Summary of 
FDA Information:

FOI Summary; NADA 039-417 (supplement); Decoquinate (Deccox); re: add young sheep; June 29, 1994 --Editor's abstract 1. GENERAL INFORMATION NADA 039-417 Sponsor: Rhone Poulenc Inc. 500 Northridge Road Suite 620 Atlanta, Georgia 30350 Established Drug Name: Decoquinate Trade Name: Deccox Marketing Status: Over The Counter Effect of
Supplement: To add a new species (young sheep) to the approved label. Indications For Use: For the prevention of
coccidiosis caused by Eimeria bakuensis, E. crandallis, E. ovinoidalis and
E. parva in young sheep. Dosage Form: Type A medicated article [6% (27.2 grams/lb)] for
use in manufacturing into
a Type C medicated feed. Route of
Administration: Oral, via feed Recommended Dosage: Thoroughly mix Deccox into
the ration at a rate to provide decoquinate at a daily dose of
22.7 mg/100 lb (0.5 mg/kg) of
body weight and
feed for
at least 28 days during periods of
exposure or
when experience indicates that coccidiosis is likely to be a hazard. 2. DRUG EFFECTIVENESS A. Pivotal Study No. 1. 1. Type of
Study: Dose Titration 2. Name and
Address of
Investigator: Dr. William J. Foreyt Department of
Veterinary Microbiology and
Pathology Washington State University Pullman, Washington 99164 3. Purpose of
the Study: To determine the effectiveness of
decoquinate for
the prevention of
coccidiosis in naturally infected feedlot lambs and
to determine the optimum dosage. 4. Test Animals: Twenty weaned lambs (average = 30.75 pounds) were
randomly allocated for
this study
.
The study
consisted of
5 groups of
4 lambs each.
The lambs were
primarily Columbia cross. Each group consisted of
castrated males and
females.
The animals were
purchased from
a herd at Deer Park, Washington. Lambs were
weighed at days 3, 11, 22 and
31 of
the experiment. Water was
provided ad libitum. 5. Feed: Feed consisted of
pelleted ration of
alfalfa (62.5%) and
barley (37.5%). Free choice pellets, hay, and

mineralized salt were
provided ad libitum. 6. Identification: Lambs were
identified by colored tags according to group. 7. Location: The study
was conducted at Washington State University, Animal Research Facilities, Pullman, WA. 8. Treatment: The treatments were
infected non medicated (infected control), infected medicated with decoquinate* 0.5 mg/kg body weight. Medication was
adjusted based on lamb weights on days 0, 7, 14, 21 and
28. *Decoquinate administered as Deccox Premix. 9. Test Duration: The medicated feed was
fed for
31 days. 10. Diagnosis: Fecal samples were
collected from
the rectum of
all lambs on experimental days 0, 4, 8, 11, 15, 22, 25 and
31. Species of
oocysts were
identified. Parameters: Clinical Observation; Weight gain; Microscopic parasitic number; and
Mortality. Results: All lambs were
passing oocysts when
the titration study
began.
The coccidia species isolated in all the lambs were
Eimeria ovinoidalis, E. ovina, E. crandallis, E. parva and
E. intricata. No mortality reported in the
study
, and

no weight differences were
present among the groups (Refer to Table 1). Decoquinate at 0.5 mg/kg body weight suppressed oocyst production by post-treatment day 31. On day 31, the
control group had an average of
8714 oocysts per gram of
feces, and

treated lambs had an average of
189 oocysts per gram of
feces. Decoquinate at 1.0 mg suppressed oocyst production on days 22, 25 and
31 of
the experiment. Decoquinate at 4 mg/kg body weight suppressed oocyst production on days 15, 18, 22, 25 and
31 of
the experiment. However, there were
no numerical differences in oocyst suppression among the treated groups. No signs of
toxicity or
palatability problems were
reported in this study
.
The data showed that decoquinate premix at 0.5, 1.0 and
4.0 mg/kg body weight is efficacious against naturally occurring coccidia infections in lambs (Refer to Table 2). Conclusion: The 0.5mg/Kg was
selected to be the optimum dose because it was
effective in the
prevention of
coccidiosis in young sheep and
treated animals gained more weight on less feed, and

they gained more weight than the sheep in the
untreated control group. Additionally, the
dose reflects the approved dose labeled for
cattle, goats and
poultry. (Eds. note: The following table consists of
6 columns.) Table 1. Summary of
Mean Weights by Treatments Decoquinate Days after treatment initiation Weight Group -3 11 22 31 gain 0 mg/g 14.0 18.1 20.6 22.7 8.7 0.3 m/kg 14.1 19.0 19.4 20.9 6.8 0.5 mg/kg 14.2 19.3 21.5 23.6 9.4 1.0 mg/kg 14.0 19.2 22.0 21.5 7.5 4.0 mg/kg 13.7 21.3 23.1 24.6 10.9 (Eds. note: The following table consists of
10 columns.) Table 2. Summary of
mean oocyst counts by treatments Decoquinate Days after treatment initiation (mg/kg body weight) 0 4 8 11 15 18 22 25 31 0 1097 7680 1292 3221 2556 4562 10,715 8357 8714 0.3 2459 1958 1542 536 551 1092 321 2903 1922 0.5 2444 10,007 3860 426 980 1032 1905 425 189 1.0 1862 1793 2037 588 1472 344 276 56 246 4.0 2273 546 632 51 128 29 11 12 32 B. Pivotal Study No. 2. 1. Type of
Study: Dose Confirmation 2. Name and
Address of
Investigator: Dwight D. Bowman, Ph.D. College of
Veterinary Medicine Cornell University Ithaca, NY. 14853 3. Purpose of
the study
: To evaluate the effectiveness of
decoquinate in feed at the
rate of
0.5 mg/kg in coccidia free lambs infected by inoculation with known species of
coccidia. 4. Test Animals: Eighteen lambs were
acquired at birth and
transferred to an isolation facility where they were
hand-reared in a coccidia-free environment.
There were
10 males and
8 females in the
initial group. 5. Feed: Initially, lambs were
fed bovine colostrum, Ultra Fresh® Lamb Milk Replacer and
Entrolyte. When
old enough to eat solid food, they were
fed Hi-Energy Lamb Pellets. 6. Identification: Fourteen of
the original 18 lambs were
selected nine males and
five females. Lambs were
identified by ear tags bearing individual numbers. Six were
assigned to non-medicated infected group and
six assigned to medicated infected group.
The remaining two were
retained as monitors, non infected non-medicated. 7. Location: The study
was conducted in the
research facilities at the
Veterinary College, Cornell University, Ithaca, NY. 8. Treatment: The treatments were
infected non-medicated (infected control) and
infected medicated with decoquinate* at 0.5 mg/kg body weight. Medication was
adjusted based on lamb weights on days 0, 7, 14, 21 and
28. *Decoquinate administered as Deccox Premix 9. Test duration: 31 days 10. Diagnosis: Necropsies of
all dead animals, microscopic identification of
asexual forms and
gamonts of
coccidia in tissues, and

identification of
oocysts in feces. 11. Parameters: Clinical observations (body
condition, fecal scores and
fecal staining around anus); weight; coccidia numbers by days and
species; and
mortality. 12. Results: None of
the lambs were
passing oocysts when
the study
began.
The two animals, non medicated non infected remained negative for
the entire period. Oocysts were
present in the
feces of
all lambs that were
inoculated. (See Table 2) The number of
oocysts shed by the infected controls was
much higher than those found in the
decoquinate treated group. Lambs in the
infected control group began dying on Day 17 of
the test and
by Day 28 the mortality was
100 per cent. (See Table 1). Necropsies and
microscopic examinations confirmed that all deaths were
caused by coccidiosis. In contrast, there were
no deaths in the
decoquinate medicated group. General body condition, fecal scores and
fecal staining around the anus were
highly favorable to decoquinate medicated lambs over the infected control animals while the latter were
alive. (Eds. note: The following table consists of
6 columns) Table 1. Average Weight and
Mortality Group Treatment Infection Ave Day-17 Weight (kg) Mortality Day 31 D/T 1 None None 7.5 19.05 0/2 2 None Yes 7.8 Dead 6/6 3 decoquinate Yes 8.06 16.08 0/6 Ed. note: The following table consists of
7 columns. Table 2. Oocysts Per Gram of
Feces (Average per Group*) Day Post Oocyst Inoculation Group Species 17 21 24 28 31 1 E. ovinoidalis 0 0 0 0 0 2 E. ovinoidalis 716,800 231,440 1,775,733 -Dead- -Dead- 3 E. ovinoidalis 37,000 200 323 0 0 1 E. bakuensis 0 0 0 0 0 2 E. bakuensis 0 40,840 3,077,067 -Dead- -Dead- 3 E. bakuensis 0 0 0 63,066 5,200 1 E. parva 0 0 0 0 0 2 E. parva 396,266 19,370 180,000 -Dead- -Dead- 3 E. parva 24,466 2,866 0 2,600 29,716 1 E. crandallis 0 0 0 0 0 2 E. crandallis 0 122,533 590,667 -Dead- -Dead- 3 E. crandallis 0 0 533 9,466 13,266 *Based on the number animals alive on a given day. Conclusion: The data collected in the
dose titration study
has been verified by the data generated in the
dose confirmation study
and together these pivotal studies have demonstrated that Decoquinate is effective in the
prevention of
coccidiosis caused by Eimeria bakuensis, E. crandallis, E. ovinoidalis and
E. parva in young sheep. 3. ANIMAL SAFETY STUDIES A. Pivotal Target Animal Safety Study 1. Name and
Address of
Investigator: Dr. William J. Foreyi Microbiology and
Pathology Washington State University Pullman, Washington 99164 2. Purpose of
the Study: (This study
is also the pivotal dose titration study
). To determine the safety of
decoquinate in lambs at doses up to 8x for
31 days. 3. Test Animals: Twenty weaned lambs (average = 30.75 pounds) were
randomly allocated for
this study
.
The study
consisted of
5 groups of
4 lambs each.
The lambs were
primarily Columbia cross. Each group consisted of
castrated males and
females.
The animals were
purchased from
a herd at Deer Park, Washington. Lambs were
weighed at days 3, 11, 22 and
31 of
the experiment. Water was
provided ad libitum. 4. Feed: Feed consisted of
pelleted ration of
alfalfa (62.5%) and
barley (37.5%). Free choice pellets, hay, and

mineralized salt were
provided ad libitum. 5. Identification: Lambs were
identified by colored tags according to group. 6. Location: The study
was conducted at Washington State University, Animal Research Facilities, Pullman, WA. 7. Treatment: The treatments were
(a) infected nonmedicated(b) infected medicated with decoquinate* 0.3 mg/kg body weight (c) infected medicated with decoquinate 0.5 mg/kg body weight (d) infected medicated with decoquinate 1.0 mg/kg body weight and
(e) infected medicated with decoquinate 4.0 mg/kg body weight.
The amount of
medicated feed was
adjusted on a weekly basis, based on weight of
the lamb in each group. 8. Test Duration: The medicated feed was
fed for
31 days. 9. Diagnosis: Fecal samples were
collected from
the rectum of
all lambs on experimental days 0, 4, 8, 11, 15, 22, 25 and
31. Species of
oocysts were
identified. 10. Parameters: Clinical Observation (signs of
toxicity); Microscopic parasitic number; and
Mortality. B. Conclusion: None of
the lambs died or
were
clinically ill during the 31 day experimental period. No signs of
toxicity or
palatability problems were
noted. All sheep were
passing oocysts when
the study
began. Feeding decoquinate as high as 4.0 mg/kg body weight (8 times the recommended dose level) for
31 days was
safe to the sheep. 5. HUMAN SAFETY A. Tolerances The tolerances for
residues of
decoquinate in sheep are 1 ppm for
muscle and
2 ppm for
liver, kidney and
fat. B. Total Residue Depletion and
Metabolism Studies A study
entitled "A Metabolism-Residue Study in Lambs with 14C-Decoquinate" was
conducted by WIL Research Laboratories. Two wethers and
two ewes, confined in metabolism cages and
weighing about 40 to 50 kg, were
treated with micronized 14C-3-decoquinate at 0.53 to 0.57 mg/kg per day (the intended dose) over a 4-day period. Dosing was
done twice a day with gelatin capsules. One wether was
used as a control.
The drug had a specific activity of
about 5.1 uCi/mg and
a radiopurity of
greater than 98%.
The lambs were
sacrificed at 8 to 12 hrs (practical zero withdrawal) after the last dose. Samples of
edible tissue were
collected and
stored under
freezer conditions. Total residue concentrations in muscle, liver and
kidney were
measured by combustion and
scintillation counting. Abdominal fat was
macerated and
extracted to give two fractions. Aliquots of
the extracts were
analyzed directly for
radioactivity after evaporation of
the solvent.
The insoluble fraction was
analyzed by combustion and
scintillation counting.
The total residue for
fat was
given as the sum of
the two fractions.
The results of
radioanalyses on the edible tissues are given in Table 1.
The total residue in each tissue is less than one-half of
the tolerances of
1 ppm for
muscle and
2 ppm for
the other edible tissues. Table 1. Average Total Residue Concentrations in Edible Tissues of
Sheep Treated at 0.5 mg/kg/day for
4 Days and
Sacrificed at Zero Withdrawal Average Total Residue in ppm Animal Liver Kidney Muscle Fat 2 (male) 0.177 0.111 0.009 0.022 3 (male) 0.271 0.130 0.024 0.031 4 (female) 0.200 0.111 0.010 0.022 5 (female) 0.222 0.108 0.010 0.003 average all 0.218 0.115 0.013 0.020 Isolates from
the lambs were
analyzed with TLC to give residue profiles. In this profiling work, four lanes were
used: Lanes A and
D were
spotted with 14C-decoquinate, while Lanes B and
C were
spotted with liver or
kidney isolates. Decoquinate represented from
20.6% to 59.3% of
the radioactivity in liver and
from 13% to 36.6% of
the radioactivity in kidney. While there was
some variability of
the percentage for
decoquinate in the
individual animals, the
profiles were
similar. As noted above, the
profiling data from
sheep show that decoquinate makes up from
20.6% to 59.3% of
the radioactivity in liver and
from 13% to 36.6% of
the radioactivity in kidney. Moreover, there appeared to be at least two other fractions.
These results compare favorably with those in rats as presented in J. Ag. Food Chem., 19, 1234 (1971), which
was
submitted to this NADA several years ago and
which
is referenced in the
final report of
the study
. In that article, it was
reported that decoquinate was
42% of
the radioactivity in rat liver and
about 38% of
the radioactivity in rat kidney. In addition, three other components were
found on TLC.
These data from
rat and
sheep demonstrate comparative metabolism in the
two species. C. Withdrawal Period The results of
the residue study
show that at 8 to 12 hours post dosing (practical zero withdrawal), the
total residue of
decoquinate is less than one-half of
the tolerances of
1 ppm for
muscle and
2 ppm for
the other edible tissues.
Therefore, a withdrawal period is not required for
the use of
decoquinate at 0.5 mg/kg/day for
the prevention of
coccidiosis in sheep. D. Regulatory Method Neither a withdrawal period nor a regulatory method is required for
this use of
decoquinate in sheep. 5. AGENCY CONCLUSIONS The data submitted in support of
this NADA satisfy the requirements of
Section 512 of
the Federal Food, Drug, and

Cosmetic Act (the Act) and
21 CFR Part 514 of
the implementing regulations.
The data demonstrate that decoquinate Type A medicated article is safe and
effective for
the prevention of
coccidiosis in young sheep caused by Eimeria ovinoidalis, E. crandallis, E. parva, and

E. bakuensis.
The tolerances for
residues of
decoquinate in sheep are 1 ppm for
muscle and
2 ppm for
liver, kidney and
fat.
The results of
the residue study
show that at 8 to 12 hours post dosing (practical zero withdrawal), the
total residue of
decoquinate is less than one-half of
the tolerances of
1 ppm for
muscle and
2 pp. for
the other edible tissues.
Therefore, a withdrawal period is not required for
the use of
decoquinate at 0.5 mg/kg/day for
the prevention of
coccidiosis in young sheep. Decoquinate for
food producing animals is generally over-the-counter. Accurate diagnosis can be made with reasonable degree of
certainty by the layman. Adequate directions for
use have been written for
the layman, and

the conditions for
use prescribed on the labeling are likely to be followed in practice.
Therefore, the
Center for
Veterinary Medicine (CVM) has concluded that this product shall have over-the-counter marketing status. Under the Center's supplemental approval policy (21 CFR 514.106(b)(2)(vii)), this is a Category II change.
The approval of
this change is not expected to have any adverse effect on the safety or
effectiveness of
this new animal drug. Accordingly, this approval did not require a reevaluation of
the safety and
effectiveness data in the
parent application. Under Section 512(c)(2)(F)(iii) of
the Act, this approval for
food-producing animals qualifies for
THREE (3) years of
marketing exclusivity beginning on the date of
approval because the supplemental application contains reports of
new clinical or
field investigations (other than bioequivalence or
residue studies) essential to the approval of
the application and
conducted or
sponsored by the applicant.
The THREE years of
marketing exclusivity applies only to the claim for
the prevention of
coccidiosis in sheep for
which the supplemental application was
approved. Labeling: #1-Blue Bird Labeling (Type A medicated article) #2-Bag Labeling (Type B medicated feed) Copies of
applicable labels may be obtained by writing to the: Freedom of
Information Office Center for
Veterinary Medicine, FDA 7500 Standish Place Rockville, MD 20855

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