I. GENERAL INFORMATION:
| NADA |
138-993 |
| Sponsor:
|
Moorman Mfg. Company
1000 North 30th Street
Quincy, IL 62301
|
| Generic
Name: |
Lasalocid |
| Trade Name: |
MoorMan's Cattle
Minerals BT Medicated |
| Notes |
Original Application 21 CFR 514.1
To provide for a medicated free-choice administered feed.
|
II. INDICATIONS FOR USE
For increased rate of weight gain
in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement
heifers).
III. DOSAGE FORM(S), ROUTE OF
ADMINISTRATION AND RECOMMENDED DOSAGE
Medicated mineral feed containing
1440 grams per ton (720 mg./lb.) lasalocid to be fed free-choice to pasture
cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers)
at a rate of 0.084 lb. to 0.277 lb. per head per day. The recommended dosage
is 60 to 200 mg. lasalocid per head per day.
IV. EFFECTIVENESS
Dose titration data was provided
by authorized reference to NADA 96-298V (see FOI dated December 14, 1984, FR
Vol. 49, No. 246, page 49449).
Three trials were conducted to
determine the effect of lasalocid on average daily gain and mineral consumption
when administered in a medicated mineral fed free-choice.
A. Study No. 4095
Investigator:
Dr. Denis Lamm
Eastern Colorado Research Center
Burdette Route
Akron, Colorado
The 92-day trial consisted of 2
pasture lots of 10 yearling steers. Two lots were fed the medicated mineral
free-choice.
(Eds. note: The following table
consists of 2 columns.)
Lasalocid Medicated Mineral
No. of Animals 20
Beginning Wt. 492.05 lb.
Final Wt. 653.9 lb.
Avg. daily mineral intake 0.22 lb. per head
Avg. daily lasalocid intake 161 mg per head
B. Study No. 4249
Investigator:
Timothy Del Curto and Dr. Dale
Weber
Department of Animal Science
Oregon State University
Corvallis, Oregon
The 84-day trial consisted of 6
pasture lots of 7 steers or heifers each. Three lots were fed the medicated
mineral free-choice and three lots were fed the unmedicated control mineral
free-choice.
(Eds. note: The following table
consists of 3 columns.)
Lasalocid Unmedicated
Medicated Mineral Mineral
No. of Animals 21 21
Beginning Wt. 653.33 lb. 650.00 lb.
Final Wt. 880.00 lb. 867.33 lb.
Avg. daily mineral intake 0.206 lb. per head 0.37 lb. per head
Avg. daily lasalocid intake 148.3 mg per head ---
Avg. daily gain 2.70 lb. per head 2.59 lb. per head
C. Study No. 3788
Investigator:
Dr. Albert Peter
Moorman Research Farm 2
Mendon, Illinois
The 84-day study consisted of 4
pasture lots of 8 steer calves each. Two lots were fed the medicated mineral
free-choice and two lots were fed the unmedicated control mineral free-choice.
(Eds. note: The following table
consists of 3 columns.)
Lasalocid Unmedicated
Medicated Mineral Mineral
No. of Animals 16 16
Beginning Wt. 492.45 lb. 492.35 lb.
Final Wt. 656.95 lb. 627.8 lb.
Avg. daily mineral intake 0.200 lb. per head 0.274 lb. per head
Avg. daily lasalocid intake 144 mg per head ---
Avg. daily gain 1.96 lb. per head 1.61 lb. per head
Summary:
The Analysis of Variance for Average
Daily Gain pooled the ten replicates from studies #4249 and #3788 and analyzed
the data without specific consideration for the heifers in study #4249. The
site by treatment interaction was not significant (P>.3533) and this term
was pooled into error. In this analysis, there was a site effect (P=.0002) but
no treatment effect (P=.1216). However, a one-tailed t test used to test for
treatment difference between treated and control animals was significant at
P=.0608. This indicated that lasalocid was effective to increase the rate of
weight gain in pasture cattle when received through consumption of Moorman's
mineral mixture.
A coefficient of variation (C.V.)
was calculated for the two effectiveness studies (#4249 and #3788) based upon
consumption of lasalocid (mg/head/day). The model used contained terms for location,
period, location by period, and error, as sources of variance. A C.V. of 43.722
was calculated based upon a mean of 146.8 mg and a calculated Mean Square Error
(MSE) = 4119.57, where C.V. = ((sqare root of MSE)/Mean)) x 100. A C.V. was
also calculated for study #4095 based upon consumption of lasalocid (mg/head/day).
The model used contained terms for period and error as sources of variance.
A C.V. of 9.4345 was calculated based upon a mean of 161.4 mg and a MSE of 231.917.
The average intake for studies
#3788, #4095 and #4113 was within the efficacious range of 60 to 200 mg per
head daily (21 CFR 558.311), and the C.V. calculated for the intake study (#4095)
was 9.4345%, which is less than the C.V. of 43.722% calculated for the two studies
(#3788 and #4113) in which effectiveness of lasalocid in free-choice mineral
mixture was established. Since the variation in intake compares favorably with
the effectiveness data the free-choice mineral mixture is effective when fed
to pasture cattle.
V. ANIMAL SAFETY
Animal safety data was provided
by authorized reference to NADA 96-298V (see FOI dated December 14, 1984, FR
Vol. 49, No. 246, page 49449; July 28, 1982, FR Vol. 47, No. 152, page 34133;
May 4, 1987, FR Vol. 52, No. 85; page 16239).
VI. HUMAN SAFETY
Human safety data was provided
by authorized references to NADA 96-298V (see FOI dated December 14, 1984, FR
Vol. 49, No. 246, page 49449; July 28, 1982, FR Vol. 47, No. 152, page 34133;
and May 4, 1987, FR Vol. 52, No. 85, page 16239).
VII. AGENCY CONCLUSIONS:
For the Center for Veterinary Medicine's
review, since this original new animal drug application relied on information
in a previously approved new animal drug application (NADA 96-298), it was treated
as if it were a supplemental new animal drug application. Therefore, under the
CVM supplemental new animal drug application policy (December 23, 1977, 42 FR
64367), this is a Category II change providing for the use of lasalocid in Moorman's
Cattle Minerals BT Medicated, as a free-choice and self-limiting supplemental
feed in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef
replacement heifers).
The new use provided by this application
does not constitute an expanded use because this is only a change in the type
of carrier for the drug. Therefore, a review of the underlying human food and
target animal safety under NADA 96-298 is not required.
Moorman Manufacturing Company provided
data demonstrating that lasalocid in Moorman's Cattle Mineral BT Medicated is
effective, while Hoffmann La Roche supplied data demonstrating safety or the
product. Therefore, this application is approved.
VIII. LABELING (Attached)
1. Moorman's Cattle Minerals BT
package label and mixing directions
Copies of this label may be obtained
by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.
