Approval Date: Sept. 22, 1997
Freedom of Information Summary
NADA 200-211
I. GENERAL INFORMATION:
NADA 200-211 Sponsor: Alpharma, Inc.
One Executive Drive
Fort Lee, New Jersey 07024Generic Name: monensin, bacitracin zinc, roxarsone Trade Name: Coban®, Albac®, 3-Nitro® Marketing Status: a. Established Name:
Monensin
Bacitracin zinc
Roxarsoneb. Trade/Proprietary Name:
COBAN®
ALBAC®
3-NITRO®c. Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of three approved Type A medicated articles (COBAN® , ALBAC®, and 3-NITRO) in Type C medicated feeds, rather than a premix incorporating all three of these compounds.
d. How Supplied:
Monensin: 50-lb bags
Bacitracin zinc: 50-lb bags
Roxarsone: 50-lb bagse. How Dispensed: OTC
f. Label Claim of Amount of Active Ingredient(s):
Monensin: 60, 100, or 200 g/lb of monensin 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:
Monensin: 90 to 110 g/ton
Bacitracin zinc: 1) 10 g/ton
2) 4 to 50 g/ton
Roxarsone: 1) 15 g/ton
2) 15 to 45.4 g/toni. Species: Broiler chickens.
j. Indications for Use: 1) For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati and E. maxima, and for increased rate of weight gain;
2) For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati and E. maxima, and for improved feed efficiency and improved pigmentation by enhancing carotenoid and xanthophyll utilization.
k. Feeding Directions Feed continuously as the sole ration.
l. Label Cautions Not for use in feeds for breeder chickens. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. For replacement chickens intended for use as cage layers only. Do not allow horses, other equines, mature turkeys or guinea fowl access to feed containing monensin. Ingestion of monensin by horses, mature turkeys and guinea fowl has been fatal. 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:
ALBAC®
Bacitracin zinc
ANADA 200-223
ALPHARMA, Inc.n. Pioneer Product/"Listed" Product:
BACIFERM®
Bacitracin zinc
NADA 46-920
Hoffmann-La Roche, Inc.COBAN®
Monensin
NADA 38-878
Elanco Animal Health3-NITRO®
Roxarsone
NADA 7-891
ALPHARMA, Inc.COBAN®/BACIFERM®/3-NITRO
monensin/bacitracin zinc/roxarsone
NADA 123-154
Hoffmann-LaRoche, 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 monensin 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. Monensin is codified under 21 CFR §558.355. Roxarsone is codified under 21 CFR §558.530. The combination of bacitracin zinc, monensin, and roxarsone is codified under 21 CFR §558.355(f)(1)(xv) and (xvi).
III. HUMAN SAFETY:
a. 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).
A tolerance for marker residues of monensin in chickens is not needed (21 CFR §556.420).
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)
b. Withdrawal Time
Based on the information in 21 CFR §558.355(f)(xv) and (xvi), a 5-day withdrawal time is required for the use of the combination of bacitracin with monensin and roxarsone in broiler chickens.
c. 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 monensin is the method developed by Eli Lilly & Co., Box 708, Greenfield, IN 46140 (Method 5801654, "Determination of Monensin in Tissues and Eggs") on file at the Center for Veterinary Medicine, Food and Drug Administration, HFV-199, 7500 Standish Place, Rockville, Maryland 20855.
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 monensin, bacitracin zinc and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.
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