Approval Date: Sept. 22, 1997
I. GENERAL INFORMATION
One Executive Drive
Fort Lee, New Jersey 07024
amprolium, ethopabate, bacitracin zinc
Amprol HI-E®, Albac®
A. Established Name:
- Bacitracin zinc
B. Trade/Proprietary Name:
- AMPROL HI-E®
C. Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (AMPROL HI-E® and ALBAC®) in Type C medicated feeds, rather than a premix incorporating both of these compounds.
D. How Supplied:
- Amprolium + Ethopabate: 50-lb bags
- Bacitracin zinc: 50-lb bags
D. How Dispensed: OTC
F. Label Claim of Amount of Active Ingredient(s):
- Amprolium + Ethopabate: 113.5 g/lb of amprolium and 36.3 g/lb of ethopabate in Type A medicated article.
- Bacitracin zinc: 50 g/lb bacitracin zinc in Type A medicated article.
G. Route of Administration: These drugs are administered orally by adding the Type A medicated articles to complete chicken feed (Type C medicated feed).
H. Labeled Dosage:
- Amprolium: 113.5 g/ton
- Ethopabate: 36.3 g/ton
- Bacitracin zinc: 4 to 50 g/ton
I. Species: Broiler chickens.
J. Indications for Use:
- to aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur in broiler chickens and replacement chickens where immunity to coccidiosis is not desired; and for increased rate of weight gain in broiler chickens raised in floor pens;
- as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur, and for improved feed efficiency in broiler chickens.
K. Feeding Directions Feed as the sole ration from the time chicks are placed on litter until past time when coccidiosis is ordinarily a hazard.
L. Label Cautions Not for chickens over 16 weeks of age. Do not feed to laying chickens. Not for use in feeds for breeder chickens. Use as sole source of amprolium. Not for use as a treatment for outbreaks of coccidiosis. Do not change litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis, and follow the instuctions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions.
M. Generic Product:
N. Pioneer Product/"Listed" Product:
Hoffmann-La Roche, Inc.
- AMPROL HI-E®
Amprolium + ethopabate
Merck & Co., Inc.
- AMPROL HI-E®/BACIFERM®
Amprolium + ethopabate/bacitracin zinc
Hoffmann-La Roche, Inc.
II. EFFECTIVENESS AND TARGET ANIMAL SAFETY
In accordance with the Center for Veterinary Medicine's policy letter dated November 2, 1989, as published in the Federal Register on January 30, 1990 (55 FR 3107), following the approval of an ANADA for a generic Type A Medicated article (ANADA 200-223, generic bacitracin zinc), ALPHARMA, Inc., is entitled to the approval of generic bacitracin zinc in combination with amprolium and ethopabate. Bioequivalence studies are not required for the approval of this generic combination (Type C Medicated feed). Bacitracin zinc is codified under 21 CFR §558.78. Amprolium and ethopabate is codified under 21 CFR §558.58. The combination of bacitracin zinc and amprolium and ethopabate is codified under 21 CFR §558.58(d)(1)(iii).
III. HUMAN SAFETY
Tolerances for the Marker Residue
The tolerances established for the pioneer bacitracin zinc product apply to the generic bacitracin zinc product.
The tolerances for residues of bacitracin from bacitracin zinc are established at 0.5 ppm (0.02 unit per gram), negligible residue, in uncooked edible tissues of chickens (21 CFR §556.70).
Tolerances for amprolium residues in chickens are established at 1.0 ppm in the uncooked liver and kidney, and 0.5 ppm in uncooked muscle (21 CFR §556.50).
Tolerances for ethopabate residues converted to m-phenetidine in chickens are established at 1.5 ppm in the uncooked liver and kidney and 0.5 ppm in uncooked muscle (21 CFR §556.260).
Based on the information in 21 CFR §558.58(d)(iii), a withdrawal time is not required for the use of the combination of bacitracin with amprolium and ethopabate in broiler and replacement chickens.
Regulatory Method for Residues
The regulatory analytical method for detection of residues of bacitracin is a microbiological test using Sarcina subflava (ATCC 7468) or Micrococcus subflavus (ATCC 10240). The method is found in Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports and Protocols, Revised October 1968, Reprinted December 1974, Nation Center for Antibiotic and Insulin Analysis, FDA, Washington, DC 20204.
Modified Method for the Determination of Bacitracin in Tissues, Test Procedure Code 9A, AL Laboratories, One Executive Dr. PO Box 1399, Fort Lee NJ 07024.
The regulatory analytical method for detection of residues of amprolium is a fluorimetric test. A description of the regulatory method is filed in the Food Additives Analytical Manual that is on display in
FDA's Freedom of Information Public Room
5600 Fishers Lane
Rockville, MD 20857.
The analytical method for the determination of ethopabate in tissues uses a gas chromatographic assay procedure that measures the 2,4 dinitrophenyl derivative of m-phenetidine produced following acid hydrolysis of ethopabate. This method is found in JAOAC 53:461 (1970).
IV. AGENCY CONCLUSIONS
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that the combination of amprolium, ethopabate, and bacitracin zinc, when used under its proposed conditions of use, is safe and effective for its labeled indications.
- Type C medicated Feed (Blue Bird) - Generic
- Type C medicated Feed (Blue Bird) - Pioneer
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