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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 141-034 Gainpro™ - supplemental approval (July 9, 1996)

Approval Date: July 9, 1996

I. GENERAL INFORMATION:

NADA 141-034
Sponsor: Hoechst-Roussel Agri-Vet Co.
P.O. Box 2500
Route 202-206
Somerville, NJ 08876-1258
Generic Name: bambermycins
Trade Name: Gainpro™
Marketing Status: Over the Counter (OTC)
Effect of Supplement: 21 CFR 558.95 currently provides for the use of bambermycins in cattle fed in confinement for slaughter for improved feed efficiency and increased rate of weight gain, and for increased rate of weight gain in pasture cattle. This supplement provides for use of a generic formulation of loose mineral free-choice Type C medicated feed for free-choice supplementation to pasture cattle.

 

II. INDICATIONS FOR USE

For increased rate of weight gain in pasture cattle (slaughter, stocker and feeder cattle) when fed on a free-choice basis in Type C medicated feed described in Table 1.

 

III. DOSAGE FORM(S), ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE

GAINPRO™ is supplied as a Type A Medicated Article in 50 lb. multi-walled bags. The Type A Medicated Article contains 10 g bambermycins per pound. The drug is administered orally by mixing the Type A Medicated Article into free-choice feed (Type C feed) to provide not less than 10 nor more than 20 mg bambermycins per head per day. The resultant free-choice feed containing bambermycins is to be fed continuously through the period in which the cattle are consuming pasture.

 

IV. EFFECTIVENESS

Pivotal Dose Titration Field Studies:

This supplemental New Animal Drug Application is based on adequate and well-controlled studies demonstrating the effectiveness of bambermycins for increased rate of weight gain in cattle consuming pasture. Four (4) pivotal studies were conducted using a randomized complete block design and 512 growing calves. The studies are summarized and evaluated below for significant differences in rate of weight gain. The 512 test animals used in these four (4) pasture studies were fullbred or crossbred animals of European and exotic breeds. Each study contained replicates of non-medicated control and medicated animals for comparison purposes. Duration of the studies ranged from 98 to 101 days. Steers and heifers were used in all studies. Eight (8) steers or heifers were randomly assigned to each pasture. The initial animal weights ranged from 235 to 300 kgs, and the studies were terminated when the animals reached 285 to 395 kgs.

During the studies the cattle were rotated across pastures within a block to minimize any effect(s) of pasture conditions. The four (4) studies are summarized as follows:

Trial No. 946-01-02-94: Ruminant Free-Choice Type C Medicated Feed

Investigator:

Dr. William C. Ellis
Colonial Farms
704 Encinas Place
College Station, TX 77845

Monitor:

Lawrence E. Deetz
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Route 202-206
Somerville, New Jersey 08876-1258

This study was conducted in Ruston, LA using 64 yearling steers and 64 yearling heifers. The cattle were fed bambermycins via loose mineral for 98 days on native coastal bermuda and bahia pastures. There were 8 animals per pasture and 8 replications of each treatment. The results were as follows:

                               Control    Bambermycins, as GAINPRO™, 120 g/ton
                               -------    ------------------------------------
Average Daily Gain (kgs/day)    0.399                    0.479
Bambermycins (mg/head/day)      0.00                    17.08          

Trial No. 946-02-02-94: Ruminant Free-Choice Type C Medicated Feed

Investigator:

Dr. Ed G. Johnson
Johnson Research
24007 Highway 20-26
Parma, ID 83660

Monitor:

Lawrence E. Deetz
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Route 202-206
Somerville, New Jersey 08876-1258

This study was conducted in Parma, ID using 64 yearling steers and 64 yearling heifers. The cattle were fed bambermycins via loose mineral for 98 days on alta fescue and ladino clover pastures. There were 8 animals per pasture and 8 replications of each treatment. The results were as follows:

                               Control    Bambermycins, as GAINPRO™, 120 g/ton
                               -------    ------------------------------------
Average Daily Gain (kgs/day)    0.542                    0.580
Bambermycins (mg/head/day)      0.00                    5.01

Trial No. 946-03-02-94: Ruminant Free-Choice Type C Medicated Feed

Investigator:

Dr. Daryl Meyer
Lucerne Enterprises
730 North Howard
Fremont, NE 68025

Monitor:

Lawrence E. Deetz
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Route 202-206
Somerville, New Jersey 08876-1258

This study was conducted in Rose, NE using 64 yearling steers and 64 yearling heifers. The cattle were fed bambermycins via loose mineral for 98 days on native rye and sorghum pastures. There were 8 animals per pasture and 8 replications of each treatment. The results were as follows:

                               Control    Bambermycins, as GAINPRO™, 120 g/ton
                               -------    ------------------------------------
Average Daily Gain (kgs/day)    0.807                    0.852
Bambermycins (mg/head/day)      0.00                    17.87

Trial No. 946-06-02-94: Ruminant Free-Choice Type C Medicated Feed

Investigator:

Dr. Mary Wray
Horton Feedlot & Research Center
5100 East County Road 70
Fort Collins, CO 80549

Monitor:

Lawrence E. Deetz
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Route 202-206
Somerville, New Jersey 08876-1258

This study was conducted in Laramie, WY using 64 yearling steers and 64 yearling heifers. The cattle were fed bambermycins via loose mineral for 101 days on native grass pasture consisting primarily of foxtail. There were 8 animals per pasture and 8 replications of each treatment. The results were as follows:

                               Control    Bambermycins, as GAINPRO™, 120 g/ton
                               -------    ------------------------------------
Average Daily Gain (kgs/day)    0.893                    0.947
Bambermycins (mg/head/day)      0.00                    21.45

Results of Efficacy Studies:

A randomized complete block design was used for all studies and the data were pooled by analysis of variance to determine the significance of the effect of bambermycins on average daily gain (ADG). A pooled analysis of the four (4) studies that tested the free-choice Type C medicated feed demonstrated that there was a significant increase in rate of weight gain with the bambermycins medicated feed when compared with the non-medicated feed.

Mixed model procedures were used to allow for the estimation of random and fixed effects and inference to the broad inference space. For average daily gain, the fixed effects included sex, treatment, and sex by treatment interaction. Random effects included site, site by treatment interaction, site by sex interaction, block within site by sex, and site by treatment by sex interaction. Treatment differences were determined using a one-sided test.

The consumption data reported as average daily consumption of bambermycins in mg per head per day from the medicated replications were evaluated weekly. These data were used to establish the average daily consumption of bambermycins for each study and for making an estimation of the of the variance in average bambermycins intake between the 7-day periods within the studies. The amount of variation in bambermycins intake was then described by calculating a Coefficient of Variation (C.V.).

Results of the pooled analysis demonstrated that bambermycins consumed at an average intake of 15.35 mg per head per day for the four studies significantly increased (P<.016) the average daily gain of cattle consuming pasture when compared with cattle not receiving bambermycins. Steers and heifers responded similarly to the treatments. Approval of the Type C feed was based on the significant increased average daily gain, an average daily consumption of bambermycins (for the combined analysis of the 4 studies) within the approved dose range of 10 and 20 mg/head/day, and an acceptable Coefficient of Variation for average daily drug intake of 51.19%. Results from the mixed model analysis are presented in the following table.

POOLED ANALYSIS

                               Control    Bambermycins, as GAINPRO™, 120 g/ton
                               -------    ------------------------------------
Average Daily Gain (kgs/day)    0.660(a)                 0.715(b)
Bambermycins (mg/head/day)      0.00                    15.35

Average daily gain means with different superscripts differ P<.016, one-sided test.

 

V. ANIMAL SAFETY

Please see Freedom of Information summary dated March 4, 1994, for Bambermycins for Pasture Cattle (slaughter, stocker and feeder cattle): NADA 141-034 (59 FR 15624, April 4, 1994).

 

VI. HUMAN FOOD SAFETY:

Please see Freedom of Information summary dated March 4, 1994, for Bambermycins for Pasture Cattle (slaughter, stocker and feeder cattle): NADA 141-034 (59 FR 15624, April 4, 1994).

 

VII. ENVIRONMENTAL ASSESSMENT

An Environmental Assessment for the original NADA for Pasture Cattle (slaughter, stocker and feeder cattle) is on file with the Food and Drug Administration, Center for Veterinary Medicine at 7500 Standish Place, Rockville, MD 20855.

 

VIII. AGENCY CONCLUSIONS:

This supplemental NADA satisfies the requirements of section 512(b) of the Federal Food, Drug and Cosmetic Act, and demonstrates that GAINPRO™ 10 (dry Type A medicated article) when used under the proposed conditions of use is safe and effective for the labeled indications.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act, this approval for food producing animals qualifies for three years marketing exclusivity beginning on the date of the 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.

Under the Center for Veterinary Medicine's supplemental new animal drug application policy (21 CFR 514.106), this is a Category II change providing for the use of bambermycins in a ruminant free-choice loose mineral Type C medicated feed, a self-limiting supplemental feed in pasture cattle (slaughter, stocker and feeder cattle). The use provided by this supplement does not constitute an expanded use because this is only a change in the type of carrier for the drug. Only animals presently receiving bambermycins under existing approvals (see 21 CFR 558.95) will receive this medicated loose mineral feed. Therefore, a review of the underlying effectiveness and safety data under NADA 141-034 is not required.

 

IX. ATTACHED LABELING

  1. GAINPRO 10 (dry Type A medicated article) and
  2. Blue Bird labeling for the ruminant free-choice Type C 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

Ed. note: The following table has 4 columns.

Table 1 Composition Ruminant Free-Choice Type C Medicated Feed

Ingredient                       International Feed No.     Percent    Pounds
-----------------------------------------------------------------------------
Defluorinated phosphate (20.5
 percent calcium, 18.5 percent
 phosphorous)                           6-01-080             42.50      850.0
Sodium chloride (salt)                  6-04-152             20.10      402.0
Calcium carbonate (38% calcium)         6-01-069             15.24      304.8
Corn distillers dried grains
 w/ solubles                            5-28-236              9.57      191.4
Magnesium oxide                         6-02-756              5.15      103.0
Vitamin and Trace Mineral
 premix(1)                              --------              3.72       74.4
Mineral oil                             --------              1.00       20.0
Yeast                                   7-05-533              0.75       15.0
Gainpro Premix (10 grams
 per pound)(2)                          --------              0.60       12.0
Iron oxide                              6-02-431              0.50       10.0
Magnesium sulfate                       6-02-758              0.32        6.4
Selenium premix (270 milligrams
 per pound)(1)                          --------              0.21        4.2
Copper sulfate                          6-01-720              0.18        3.6
Potassium sulfate                       6-06-098              0.16        3.2
                                                            ------     ------
                                                            100.00     2000

(1) Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(2) To provide 120 grams bambermycins/ton.