Summary of 
FDA Information:
 
  

Approval Date: May 13, 1987 

Freedom of 
Information Summary
NADA 138-993

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.