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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 096-298 Bovatec - supplemental approval (July 26, 1993)

I. GENERAL INFORMATION:

NADA096-298
Sponsor:Hoffmann-La Roche Inc.
Nutley, NJ 07110
Generic Name:lasalocid
Trade Name:Bovatec
Marketing Status:Over the Counter (OTC)
Effect of Supplement:This supplement provides for use of a Roche formulation of a ruminant free-choice liquid Type C medicated feed for free-choice supplementation of pasture cattle.

II. INDICATIONS FOR USE

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

III. DOSAGE:

A.DOSAGE FORMBovatec Type A medicated articles are available in dry (concentration of 68 grams lasalocid per pound) and liquid (90.8 grams lasalocid per pound) forms.
B.ROUTE OF ADMINISTRATIONOral
C.RECOMMENDED DOSAGES:

Use Level
Feed continuously on a free-choice basis to provide not less than 60 nor more than 200 mg/head/day.

Indications for Use
For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

IV. EFFECTIVENESS:

Roche Ruminant Free-Choice Liquid Type C Lasalocid Medicated Feed

Three well-controlled clinical studies were conducted with one formulation of a lasalocid (150 g/ton) liquid Type C medicated feed to demonstrate consumption of the drug with variation less than or equal to the variation (CV = 35.07) in the studies used to establish the effectiveness of lasalocid in self-limiting free-choice supplemental feeds (approved 2/12/86). These studies each had three replicates. Lasalocid intake for the three studies was 171, 139, and 146 mg/head/day which are all within the 60-200 mg/head/day approved dose of lasalocid to pasture cattle. The coefficient of variation for intake was 33.9% for these three studies.

Oklahoma Study

This study was conducted at USDA ARS Forage and Livestock Research Lab, El Reno, Oklahoma, by Dr. W.A. Phillips.

Thirty-six stocker steers, approximately eight months old with average initial weight 629 pounds, were fed for 98 days on bermudagrass pastures. Each treatment was replicated three times with 12 animals per treatment. The ruminant free-choice liquid Type C medicated feed was available from lick tanks.

Average Consumption (head/day)
Type C Liquid Feed 2.28 lbs.
Lasalocid 171 mg

Illinois Study

This study was conducted at Southern Illinois University, Carbondale, Illinois, by Dr. H. D. Woody.

Thirty-six steers, approximately 10 months old with average initial weight 526 pounds, were fed for 98 days on orchardgrass pastures supplemented with sudangrass hay. Each treatment was replicated three times with nine animals per replicate. The ruminant free-choice liquid Type C medicated feed was available from lick tanks.

Average Consumption (head/day)
Type C Liquid Feed 1.85 lbs.
Lasalocid 139 mg

Colorado Study

This study was conducted at the Colorado State University, Fort Collins, Colorado, by Dr. L.R. Rittenhouse.

Thirty-six steers, approximately 6 months old, with average initial weight 440 pounds, were fed for 98 days on blue grama grass and buffalograss pastures. Each treatment was replicated three times with 12 animals per replicate. The ruminant free-choice liquid Type C medicated feed was available from lick tanks.

Average Consumption (head/day)
Type C Liquid Feed 1.94 lbs.
Lasalocid 146 mg

V. ANIMAL SAFETY:

Please see Freedom of Information summary dated December 2, 1985, for Lasalocid (NADA 096-298) for Pasture Cattle Fed on a Free-Choice Basis: 51 FR. February 12, 1986, pp. 5162-3 approval.

VI. HUMAN SAFETY:

Please see Freedom of Information summary dated December 2, 1985, for Lasalocid (NADA 096-298) for Pasture Cattle Fed on a Free-Choice Basis: 51 FR. February 12, 1986, pp. 5162-3 approval.

VII. AGENCY CONCLUSIONS:

This supplemental NADA satisfies the requirements of section 512(b) of the Federal Food, Drug and Cosmetic Act, and demonstrates that Bovatec ® 68 (dry Type A medicated article) and Bovatec ® 20 (liquid Type A medicated article), when used under the proposed conditions of use is safe and effective for the labeled indications. The ruminant free-choice liquid Type C medicated feed labeling must indicate a two month after manufacture expiration date.

Under the Center for Veterinary Medicine's supplemental new animal drug application policy-(21 CFR 5 14.106), this is a Category II change providing for the use of lasalocid in a ruminant free-choice liquid Type C medicated feed, a self-limiting supplemental feed in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

The use provided by this supplement does not constitute an expanded use because this is only a change in type of carrier for the drug. Only animals presently receiving lasalocid under existing approvals (see 21 CFR 558.31l) will receive this medicated liquid feed. Therefore, a review of the underlying effectiveness and safety data under NADA 096-298 is not required.

VIII. LABELING (Attached)

  • Bovatec® 68 (dry Type A medicated article)
  • Bovatec® 20 (liquid Type A medicated article)
  • Blue Bird labeling for the ruminant free-choice liquid Type C medicated feed.

Copies of applicable labels 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.