Approval Date: Sept. 22, 1997
I. GENERAL INFORMATION
One Executive Drive
Fort Lee, New Jersey 07024
salinomycin, bacitracin zinc
A. Established Name:
- Bacitracin zinc
B. Trade/Proprietary Name:
C. Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (SACOX® and ALBAC ® in Type C medicated feeds, rather than a premix incorporating both of these compounds.
D. How Supplied:
- Salinomycin: 50-lb bags
- Bacitracin zinc: 50-lb bags
E. How Dispensed: OTC
F. Label Claim of Amount of Active Ingredient(s):
- Salinomycin: 30 or 60 g/lb of salinomycin 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:
- Salinomycin: 40 to 60 g/ton
- Bacitracin zinc: 10 to 50 g/ton
I. 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.
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. May be fatal if fed to adult turkeys or to horses. Not approved for use with pellet binders.
M. Generic Product:
N. Pioneer Product/"Listed" Product:
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 salinomycin. 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. The combination of bacitracin zinc and salinomycin is codified under 21 CFR §558.550 (b) (1) (vii).
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).
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.
Based on the information in 21 CFR §558.550(b)(1)(vii), a withdrawal time is not required for the use of the combination of bacitracin and salinomycin 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, 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.
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 and bacitracin zinc, 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