ANADA 200-143 Sacox, 3-Nitro, Baciferm - original approval

Approval Date: April 22, 1994

I. GENERAL INFORMATION:

1. Established Name: Salinomycin sodium, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Bacitracin zinc
2. Trade/Proprietary Name: Sacox, 3-Nitro, Baciferm

3. Dosage Form: Type A medicated articles

   NOTE: This ANADA provides for the combined use of three approved Type A medicated articles (Sacox, 3-Nitro and Baciferm) in Type C medicated feeds, rather than a premix incorporating all of these compounds.

4. How Supplied:

   Salinomycin sodium: 50-lb bags
   Roxarsone: 50-lb bags
   Bacitracin zinc: 50-lb bags

5. How Dispensed: OTC

6. Label Claim of Amount of Active Ingredient(s):

   • Salinomycin sodium: 30 g/lb of Type A medicated article
   • Roxarsone: 10, 20, and 50 % roxarsone in Type A medicated article
   • Bacitracin zinc: 10, 25, 40 and 50 g/lb of Type A medicated article

7. Route of Administration:

   These drugs are administered orally by adding the Type A medicated articles to complete broiler feed (Type C medicated feed).

8. Labeled Dosage:

   • Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066 %)
   • Roxarsone: 34.1 g/ton (0.00375 %)
   • Bacitracin zinc: 10 to 50 g/ton (0.00011-0.0055 %)
9. Species: Broiler Chickens

10. 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; and for increased rate of weight gain and improved feed efficiency.

11. Generic Product:

    • Sacox
      Salinomycin sodium
      ANADA 200-075
      Hoechst-Roussel Agri-Vet Company

12. Pioneer Product/"Listed" Product:

    • Bio-Cox
      Salinomycin sodium
      NADA 128-686
      Agri-Bio Corporation
    • 3-Nitro
      Roxarsone (3-nitro-4-hydroxyphenylarsonic acid);
      NADA 007-891
      A.L. Laboratories, Inc.
    • Baciferm
      Bacitracin zinc
      NADA 046-920
      American Cyanamid Co.
    • Bio-Cox/3-Nitro/Baciferm
      Salinomycin sodium/Roxarsone/Bacitracin zinc
      NADA 139-190
      American Cyanamid Co.
13. Date of Approval: 04/22/94

II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS:

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 generic Type A medicated article (ANADA 200-075; genetic salinomycin sodium), Hoechst-Roussel Agri-Vet Company is entitled to the approval of generic salinomycin in combination with roxarsone and bacitracin zinc. 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 zinc is codified under 21 CFR § 558.78. Roxarsone (3-Nitro) is codified under 21 CFR § 558.530. The combination of salinomycin sodium, bacitracin zinc and roxarsone is codified under 21 CFR § 558.550(a) and (b)(1)(ix).

III. 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 generic 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 zinc 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
As specified in 21 CFR § 558.550(b)(1)(ix), a 5-day withdrawal time is required for the combination of bacitracin zinc, 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 titled "Arsenic (Total) Residues in Animal Tissues, Spectrophotometric Method" published in AOAC, 14th Edition 41.009, page 777.

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 sodium, bacitracin zinc and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.