Approval Date: Sept. 22, 1997
I. GENERAL INFORMATION
One Executive Drive
Fort Lee, New Jersey 07024
clopidol, bacitracin zinc, roxarsone
Coyden 25®, Albac®, 3-Nitro®
A. Established Name:
- Bacitracin zinc
B. Trade/Proprietary Name:
- COYDEN 25®
C. Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of three approved Type A medicated articles (COYDEN 25®, ALBAC®, and 3-NITRO® in Type C medicated feeds, rather than a premix incorporating these three compounds.
D. How Supplied:
- Clopidol: 50-lb bags
- Bacitracin zinc: 50-lb bags
- Roxarsone: 50-lb bags
E. How Dispensed: OTC
F. Label Claim of Amount of Active Ingredient(s):
- Clopidol: 113.5 g/lb of clopidol in Type A medicated article
- Bacitracin zinc: 50 g/lb bacitracin zinc in Type A medicated article
- Roxarsone: 45.4 g/lb roxarsone 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:
- Clopidol: 113.5 g/ton
- Bacitracin zinc: 4 to 25 g/ton
- Roxarsone: 45.4 g/ton
I. Species: Broiler chickens.
J. Indications for Use: As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati and E. brunetti, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
K. Feeding Directions: Feed continuously as the sole ration.
L. Label Cautions: Do not feed to chickens over 16 weeks of age. Not for use in feeds for breeder chickens. Use as the sole source of organic arsenic. Poultry should have access to drinking water at all times. Drug overdosage or lack of water intake may result in leg weakness or paralysis. Withdraw 5 days before slaughter.
M. Generic Product:
N. Pioneer Product/"Listed" Product:
Hoffmann-La Roche, Inc.
- COYDEN 25®
- COYDEN 25®/BACIFERM®/3-NITRO®
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 clopidol and roxarsone. 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. Clopidol is codified under 21 CFR §558.175. Roxarsone is codified under 21 CFR §558.530. The combination of bacitracin zinc, clopidol, and roxarsone is codified under 21 CFR §558.175(c)(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).
The tolerances for residues of clopidol are established at 15 ppm in uncooked liver and kidney and 5 ppm in uncooked muscle of chickens (21 CFR §556.160).
Tolerances for arsenic residues (from roxarsone) are established at 0.5 ppm in uncooked muscle and 2 ppm in uncooked edible by-products of chickens (21 CFR §556.60).
Based on the information in 21 CFR §558.175(c)(1)(iii), a 5-day withdrawal time is required for the use of the combination of bacitracin and clopidol and roxarsone in broiler 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 analytical method for the determination of clopidol in tissues uses a gas chromatographic assay procedure. This method is found in Official Methods of Analysis of AOAC International, 16th edition.
The analytical method for the determination of roxarsone in tissues is a spectrophotometric method. The method is titled "Arsenic (Total) Residues in Animal Tissues, Spectrophotometric Method" published in Official Methods of Analysis of AOAC International, 16th edition.
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 clopidol, bacitracin zinc and roxarsone, 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