Approval Date: March 4, 1994
I. GENERAL INFORMATION:
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258
salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin methylene disalicylate
Sacox, 3-Nitro, BMD
Over the Counter (OTC)
Pioneer Product/"Listed" Product:
Roxarsone (3-nitro-4-hydroxyphenylarsonic acid);
A.L. Laboratories, Inc.
Bacitracin methylene disalicylate
A.L. Laboratories, Inc.
Salinomycin sodium/Roxarsone/Bacitracin methylene disalicylate
II. INDICATIONS FOR USE
For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for increased rate of weight gain.
Type A medicated articles
NOTE: This ANADA provides for the combined use of three approved Type A medicated articles (Sacox, 3-Nitro and BMD) in Type C medicated feeds, rather than a premix incorporating all of these compounds.
ROUTE OF ADMINISTRATION
These drugs are administered orally by adding the Type A medicated articles to complete broiler feed (Type C medicated feed).
40 to 60 g/ton (0.0044-0.0066%)
45.4 g/ton (0.00044-0.0055%)
Bacitracin methylene disalicylate:
4 to 50 g/ton (0.005%)
IV. & V. EFFECTIVENESS AND ANIMAL SAFETY :
In accordance with the Center'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 genetic Type A medicated article (ANADA 200-075; genetic salinomycin sodium), Hoechst-Roussel Agri-Vet Company is entitled to the approval of genetic salinomycin in combination with roxarsone and BMD. Bioequivalence studies are not required for the approval of this generic combination (Type C medicated feed). Salinomycin sodium is codified under 21 CFR § 558.550. Bacitracin methylene disalicylate is codified under 21 CFR § 558.76. Roxarsone (3-Nitro) is codified under 21 CFR § 558.530. The combination of salinomycin sodium, bacitracin methylene disalicylate and roxarsone is codified under 21 CFR § 558.550(a) and (b)(1)(iv).
VI. HUMAN FOOD SAFETY:
In accordance with the Center's policy letter dated November 2, 1989, as published in the Federal Register on January 30, 1990 (55 FR 3107), tissue residue studies are not required for the approval of this genetic combination (Type C medicated feed).
Tolerances/Safe Concentrations for Residues
The safe concentration established for the pioneer salinomycin sodium product applies to the generic salinomycin sodium product. The safe concentrations for total salinomycin residues in the uncooked edible tissues of broiler chickens were established as 0.6 ppm in muscle, 1.8 ppm in liver, and 1.2 ppm in skin/fat.
Tolerances for residues of bacitracin from bacitracin methylene disalicylate are established at 0.5 ppm negligible residues in uncooked edible tissues of chickens (21 CFR § 556.70).
Tolerances of arsenic (from roxarsone) are established at 0.5 ppm in muscle and 2 ppm in edible by-product (21 CFR § 556.60) with liver as the target tissue.
- Withdrawal Time
Based on the information in 21 CFR § 558.550Co)(1)(iv), a 5-day withdrawal time is required for the combination of bacitracin methylene disalicylate, roxarsone and salinomycin.
Regulatory Method for Residues
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.
A microbiological assay method is used to assay tissues for bacitracin residues. The method entitled "Modified Microbiological Method for Determination of Bacitracin in Tissues" is on file at the Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
A spectrophotometric method is used to assay tissues for roxarsone residues. The method is entitled "Arsenic (Total) Residues in Animal Tissues, Spectrophotometric Method" published in AOAC, 14th Edition 41.009, page 777.
VII. 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 sodium, bacitracin methylene disalicylate, and roxarsone when used under its proposed conditions of use, is safe and effective for its labeled indications.
- Blue Bird label for the generic Type C medicated feed for broiler chickens.
- Blue Bird label for the pioneer Type C medicated feed for broiler chickens.
Copies of applicable labels may be obtained by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.