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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 141-034 GAINPRO™ - supplemental approval (March 10, 1998)

Approval Date: March 10, 1998

I. GENERAL INFORMATION:

NADA141-034
Sponsor:Hoechst Roussel Vet
P.O. Box 4915
30 Independence Blvd.,
Warren, New Jersey 07059
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 loose mineral free-choice Type C medicated feed (Trade Name: Vigortone GP Grazer) 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 Vigortone’s Type C medicated loose mineral feed.

 

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 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. Three (3) pivotal studies were conducted using a randomized complete block design and 384 growing calves. The studies are summarized and evaluated below for significant differences in rate of weight gain. The 384 test animals used in these three (3) 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 99 to 114 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 230 to 265 kgs, and the studies were terminated when the animals reached 298 to 354 kgs. During the studies the cattle were rotated across pastures within a block to minimize any effect(s) of pasture conditions. The three (3) studies are summarized as follows:

Trial No. 946-02-02-93-SP: Free-Choice Type C Medicated Feed (Vigortone GP Grazer)

Investigator:

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

Monitor:

Lawrence E. Deetz
Hoechst Roussel Vet
P.O. Box 4915
30 Independence Blvd.,
Warren, New Jersey 07059

This study was conducted in Ruston, LA, using 64 yearling steers and 64 yearling heifers. The cattle were fed bambermycins via loose mineral for 106 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) 0.503 ..........................0.567

Bambermycins (mg/head/day) 0.00......................... . 12.18

Trial No. 946-05-02-93-SP: Free-Choice Type C Medicated Feed (Vigortone GP Grazer)

Investigator:

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

Monitor:

Lawrence E. Deetz
Hoechst Roussel Vet
P.O. Box 4915
30 Independence Blvd.,
Warren, New Jersey 07059

This study was conducted in Tazewell, VA, using 64 yearling steers and 64 yearling heifers. The cattle were fed bambermycins via loose mineral for 114 days on native timothy and 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). 0.825...................... 0.860

Bambermycins (mg/head/day).. 0.00....................... 24.66

Trial No. 946-06-02-93-SP:Free-Choice Type C Medicated Feed (Vigortone GP Grazer)

Investigator:
Dr. Daryl Meyer
Lucerne Enterprise
730 North Howard
Fremont, NE 68025

Monitor:

Lawrence E. Deetz
Hoechst Roussel Vet
P.O. Box 4915
30 Independence Blvd.,
Warren, New Jersey 07059

This study was conducted in Rose, NE, using 64 yearling steers and 64 yearling heifers. The cattle were fed bambermycins via loose mineral for 99 days on 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)............ 0.661 ....................0.715

Bambermycins (mg/head/day)............. 0.00 ....................22.34

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 three (3) 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. For daily consumption, the fixed effects included sex, week, and sex by week interaction. Random effects included site, site by sex interaction, block within site by sex, site by week interaction, and site by sex by week interaction. All terms regarding the treatment and its interactions were dropped from the full model in the latter analysis. The amount of variation in bambermycins intake was then described by calculating a Coefficient of Variation (C.V.). The C.V. was calculated using the least squares mean from the mixed model described above, and the square root of the residual error from the mixed model fit only to medicated feed intake results. All terms regarding treatment and its interactions were dropped from the full model in the latter analysis.

Results of the pooled analysis demonstrated that bambermycins consumed at an average intake of 19.73 mg per head per day for the three studies significantly increased (P<.019) the average daily gain of cattle consuming pasture when compared with cattle not receiving bambermycins. Steers and heifers responded similarly to the treatments.

Conclusions: Approval of the Type C feed was based on the significant increased average daily gain, an average daily consumption of bambermycins within the approved dose range of 10 and 20 mg/head/day, and a sufficiently high Coefficient of Variation for average intake of 35.99%. 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)... 0.663a....................0.714b

Bambermycins (mg/head/day)... 0.00....................... 19.73

Average daily gain means with different superscripts differ P<.019.

 

V. ANIMAL SAFETY

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

 

VII. AGENCY CONCLUSIONS

This supplemental NADA satisfies the requirements of section 512(b) of the Federal Food, Drug and Cosmetic Act, and demonstrates that GAINPRO&trade; 10 (dry Type A medicated article) when provided in Vigortone’s GP Grazer free-choice Type C medicated loose mineral feed is safe and effective for the labeled indications.

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 Vigortone’s free-choice Type C medicated loose mineral 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. Therefore, a review of the underlying effectiveness and safety data under NADA 141-034 is not required.

Under section 512(c)(2)(F)(iii) of the FFDCA, this approval for food producing animals qualifies for three years marketing exclusivity beginning on the date of the approval because the supplemental application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) required for the approval of the application and conducted or sponsored by the applicant. The three years of marketing exclusivity applies only to the use of bambermycins with the proprietary free-choice feed product as provided for in the supplemental application.

 

VIII. LABELING (Attached)

  1. GAINPRO ™ 10 (dry Type A medicated article) and 
  2. Vigortone GP Grazer (Vigortone’s free-choice Type C medicated loose mineral 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