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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
monensin
130-736
COBAN;
monensin
monensin sodium
095-735
Rumensin® 80 Type A Medicated Article
monensin sodium
095-735
Rumensin
monensin (as monensin sodium)
115-581
Rumensin®
Monensin Sodium
monensin sodium, bacitracin methylene disalicylate
140-937
COBAN®, BMD®
monensin sodium, bacitracin methylene disalicylate
monensin sodium, tylosin phosphate
104-646
Rumensin®, Tylan®
monensin sodium, tylosin phosphate
Monensin Sodium; Bacitracin Methylene Disalicylate
140-937
COBAN®, and

BMD®,; No Trade Name Proposed for
Combination
Monensin Sodium; Bacitracin Methylene Disalicylate
monensin sodium; Tylosin Phosphate
104-646
RUMENSIN; TYLAN ;
monensin sodium; Tylosin Phosphate
Monensin, Bacitracin methylene disalicylate
141-140
COBAN®, BMD®
Monensin, Bacitracin methylene disalicylate
Monensin, Bacitracin methylene disalicylate, Roxarsone
141-138
COBAN®, BMD®, 3-NITRO®
Monensin, Bacitracin methylene disalicylate, Roxarsone
monensin, bacitracin zinc, roxarsone
200-211
Coban®, Albac®, 3-Nitro®
monensin, bacitracin zinc, roxarsone
Monensin, Bambermycin
140-955
COBAN®, FLAVOMYCIN®
Monensin, Bambermycin
Monensin, Roxarson
141-139
COBAN®, 3-NITRO
Monensin, Roxarson
Monensin, Tylosin phosphate
141-164
COBAN®, TYLAN®
Monensin, Tylosin phosphate
Monesin, virginiamycin
141-110
Coban®, Stafac®
Monesin, virginiamycin

                                                                   
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Summary of 
FDA Information:

Approval Date: March 23, 1990 Freedom of
Information Summary NADA 130-736 I. GENERAL INFORMATION: NADA 130-736 Sponsor: Elanco Products Company A Division of
Eli Lilly and
Company Lilly Corporate Center Indianapolis, IN 46285 Generic Name: Monensin Trade Name: COBAN® Marketing Status: This supplemental NADA (130-736) provides for
a change in treatment regimen from
a ten-week feeding period to a continuous feeding r growing turkeys. II. INDICATIONS FOR USE For the prevention of
coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and
E. gallopavonis. III. DOSAGE FORM(S), ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE Dosage form and
route: Medicated premix for
inclusion in finished feeds. Recommended dosage: Monensin, 54 through 90 g/ton (60 to 100 ppm) of
feed. IV. EFFECTIVENESS Efficacy data may be found in the
FOI Summary made available following initial approval of
NADA 130-736 on April 24, 1987, as published in the
Federal Register (Vol. 52, No. 83, pg. 15718) April 30, 1987. V. ANIMAL SAFETY Target animal safety data may be found in the
FOI Summary made available following initial approval of
NADA 130-736 on April 24, 1987, as published in the
Federal Register (Vol. 52, No. 83, pg. 15718) April 30, 1987. Succinctly, these data previously summarized in the
April 24, 1987, FOI Summary show that monensin is not toxic to growing turkeys when
fed at 110 g/ton for
17 weeks (20 g/ton above highest approval level).
A . Pivotal Study A pivotal study
was conducted in mature turkeys under
simulated use conditions in support of
the extended use of
monensin in growing turkeys. Six hundred Nicholas White turkeys, 12 weeks of
age and
naive to monensin, were
purchased and
acclimated for
an additional 12 weeks. Two hundred toms and
200 hens were
then randomly selected and
distributed to 16 floor pens of
25 birds each in the
poultry house. Treatment groups were
0, 90, 180, and

450 g/ton monensin, with two pens of
each sex per treatment group as follows: (Eds. note: The following table consists of
8 columns.) ------No. of
Turkeys------- Treatment Monensin Treatment No. Replicates Per --Per Group-- Group (g/ton) (ppm) Hens Toms Replicate Hens Toms 00 0 0 2 2 25 50 49* 01 90 99 2 2 25 50 50 02 180 198 2 2 25 50 50 03 450 495 2 2 25 50 50 Totals: 200 199 * One turkey died prior to start of
study
.
A turkey ration with these monensin treatments was
provided ad libitum during the four-week treatment period. Birds were
observed twice daily for
any changes in general physical condition or
behavior during the study
. Body weight, feed consumption, and

feed conversion data were
collected and
analyzed. Daily mortality was
recorded.
A gross post-mortem examination was
conducted on all birds that died or
were
killed in extremis during the study
, as well as five/sex/dose randomly-preselected birds from
each replicate killed for
necropsy at study
termination. Findings were
recorded and
tabulated.
There was
a dose-related increase in the
incidence and
severity of
physical signs of
toxicity at the
180 and
450 g/ton monensin treatment levels. Recumbency and
dyspnea were
the most consistent clinical signs observed. Anorexia was
evident from
the decreased food consumption values from
the 180 and
450 g/ton dose groups. Body weight gain and
feed efficiency were
depressed at these levels. Mortality increased in a dose-related manner.
The average mortality rates for
the 0, 90, 180, and

450 g/ton treatment groups were
0, 0.5, 23, and

65%, respectively. One turkey in the
90 g/ton group showed dyspnea and
recumbency during the second week of
the study
, but subsequently was
apparently normal and
had no gross lesions on necropsy at the
end of
the study
. Gross post-mortem lesions were
nonspecific.
The incidence of
pallor in cardiac and
skeletal muscles was
present at all monensin levels and
appeared to increase with increasing doses of
monensin levels and
appeared to increase with increasing doses of
monensin in the
feed. In conclusion, mature turkeys continuously fed a complete ration containing 180 and
450 g monensin/ton of
feed for
one month had increased mortality. Clinical signs of
anorexia, dyspnea, and

recumbency, together with pallor of
cardiac and
skeletal muscles, also increased in incidence and
severity. Dose-related decreases in body weight gain, feed consumption, and

feed consumption, and

feed efficiency occurred.
These compound-related effects were
restricted to the exaggerated dose levels of
180 and
450 g/ton, equivalent to 198 and
495 ppm monensin, respectively.
The data from
this study
, coupled with that shown in the
referenced FOI Summary, show that monensin at 90 g/ton can be safely fed to growing turkeys with the restriction of
"do not feed to mature turkeys," as provided by product labeling. Names and
address of
investigators who did the study
: Dr. M. N. Novilla and
Mr. R.L. Van Duyn Lilly Research Laboratories Greenfield, IN 46140 B. Corroborative Study Dr. Malcolm Reid, University of
Georgia, Athens, Georgia 30602, in a noncontrolled study
, dosed monensin-naive turkeys of
various ages above ten weeks with the range of
monensin dosages approved for
coccidiosis prevention in turkeys up to ten weeks of
age. To ensure consumption, these monensin-naive turkeys were
starved for
24 hours, fed the appropriate monensin concentration for
two or
three weeks, starved 36 hours, and

again fed monensin for
another two to three weeks. In this series of
three experiments with turkeys from
14 to 70 weeks of
age fed either 54 or
90 grams monensin per ton of
feed, no mortality or
morbidity occurred. Data are shown in Table 1. (Eds. note: The following table consists of
9 columns.) Table 1 Feeding of
Monensin to Older Turkeys Naive to Monensin Expt. First --Monensin-- --Second-- ----Monensin---- No. Age and
Sex No. Starvation g/ton Wks. Starvation Wks. Mortality 1 14-wk. hens; 12 24 hr. 0 0 36 hr. 0 0 1/2 large 12 24 hr. 54 2 36 hr. 2 0 1/2 small 12 24 hr. 90 2 36 hr. 2 0 whites 24 0 0 0 36 hr. 0 0 24 0 54 2 36 hr. 2 0 24 0 90 2 36 hr. 2 0 2 70-wk. toms; 15 24 hr. 54 3 36 hr. 2 0 large, white 15 24 hr. 90 3 36 hr. 2 0 3 14-wk. toms 10 24 hr. 54 2 36 hr. 3 0 24-wk. toms 10 24 hr. 90 2 36 hr. 3 0 VI. HUMAN SAFETY: Human safety data may be found in the
FOI Summary made available following initial approval of
NADA 130-736 on April 24, 1987, as published in the
Federal Register (Vol. 52, No. 83, pg. 15718) April 30, 1987. VII. AGENCY CONCLUSIONS: The data submitted in support of
this supplemental NADA comply with the requirements of
Section 512 of
the act and
demonstrate that COBAN (monensin), when
used under
its proposed conditions of
use, is safe and
effective. Coban (monensin), was
previously approved in chickens and
turkeys with a ten-week feeding period (21CFR558.355).
This supplemental provides for
a change in the
dosing regimen from
the 10 week feeding period to growing turkeys. In support of
the safe use of
Coban in growing turkeys, the
firm submitted a pivotal study
and a corroborative study
which demonstrated the drug is safe for
use in growing turkeys. No additional efficacy are necessary. Data generated in turkeys up to 10 weeks of
age are sufficient to approve Coban in growing turkeys. Proper use by non-veterinarians can be expected because poultry producers routinely use medicated feed containing an animal drug for
the prevention of
coccidiosis in growing turkeys. Directions are clearly written and
there is reasonable certainty that the
conditions for
use, including mixing directions, on the label can and
will be followed by the producer.
The Agency has concluded that this product can be approved for
over-the-counter use. Approval of
this supplemental NADA will not
significantly increase human exposure to residues of
the drug in edible tissues because the product is already regulated for
use in turkeys under
21CFR558.355. Because total monensin residues will not
exceed the safe concentration at zero withdrawal, establishing a tolerance for
a marker residue in a target tissue is not necessary. VIII. LABELING (Attached) 1. Medicated feed 50 pound bag label 2. Medicated premix Type A article Copies of
these labels may be obtained by writing to the: Food and
Drug Administration Freedom of
Information Staff (HFI-35) 5600 Fishers Lane Rockville, MD 20857

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