NADA 138-993 MoorMan's Cattle Minerals BT Medicated - original approval

Approval Date: May 13, 1987

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
Marketing Status:

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 Medicated Mineral Unmedicated 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 Medicated Mineral Unmedicated 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.