Approval Date: September 22, 1997
Freedom of Information Summary
NADA 200-209
I. GENERAL INFORMATION:
NADA 200-209 Sponsor: Alpharma, Inc.
One Executive Drive
Fort Lee, New Jersey 07024Generic Name: salinomycin, bacitracin zinc, roxarsone Trade Name: Sacox®, Albac®, 3-Nitro® Marketing Status: a. Established Name:
Salinomycin
Bacitracin zinc
Roxarsoneb. Trade/Proprietary Name:
SACOX®
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 (SACOX®, ALBAC®, and 3-NITRO®) in Type C medicated feeds, rather than a premix incorporating these three compounds.
d. How Supplied:
Salinomycin: 50-lb bags
Bacitracin zinc: 50-lb bags
Roxarsone: 50-lb bagse. How Dispensed: OTC
f. Label Claim of Amount of Active Ingredient(s):
Salinomycin: 30 and 60 g/lb of salinomycin 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:
Salinomycin: 40 to 60 g/ton
Bacitracin zinc: 10 to 50 g/ton
Roxarsone: 34.1 g/toni. Species: Broiler chickens.
j. Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati, and for increased rate of weight gain and improved feed efficiency.
k. Feeding Directions Feed continuously as the sole ration.
l. Label Cautions Do not feed to laying chickens. 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. May be fatal if fed to adult turkeys or to horses.
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.SACOX®
Salinomycin
ANADA 200-075
Hoechst-Roussel Vet3-NITRO®
Roxarsone
NADA 7-891
ALPHARMA, Inc.SACOX®/BACIFERM®/3-NITRO®
Salinomycin/bacitracin zinc/roxarsone
NADA 200-143
Hoechst-Roussel VetII. 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 salinomycin 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. Salinomycin is codified under 21 CFR §558.550. Roxarsone is codified under 21 CFR §558.530. The combination of bacitracin zinc, salinomycin, and roxarsone is codified under 21 CFR §558.550 (b) (1) (ix).
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).
Under NADA 128-686 a tolerance for salinomycin was not required because residue levels in all three broiler tissues (muscle, liver, and skin/fat) were significantly below the established safe concentration for total residues.
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 §558.550(b)(1)(ix), a 5-day withdrawal time is required for the use of the combination of bacitracin with salinomycin 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, National 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.
Under NADA 128-686 a regulatory method for salinomycin was not required because residue levels in all three broiler tissues (muscle, liver, and skin/fat) were significantly below the established safe concentration for total residues.
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 salinomycin, bacitracin zinc and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.
Attached labeling: 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