ANADA 200-086 Sacox, 3-Nitro, Albac - original approval

Approval Date: March 28, 1994

I. GENERAL INFORMATION:

1. Established Name:

   Salinomycin sodium
   Roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
   Bacitracin zinc

2. Trade/Proprietary Name:

   Sacox
   3-Nitro
   Albac

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 Albac) 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, 50% roxarsone in Type A medicated article
   Bacitracin zinc: 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 % )
   oxarsone: 45.4 g/ton (0.005%)
   Bacitracin zinc: 4 to 50 g/ton (0.00044-0.0055%)

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, 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 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 7-891
    A.L. Laboratories, Inc.

    Albac
    Bacitracin zinc
    NADA 098-452
    A.L. Laboratories, Inc.

    Bio-Cox/3-Nitro/Albac Salinomycin sodium/Roxarsone/Bacitracin zinc
    NADA 137-536
    Agri-Bio Corporation

    Date of Approval: March 28, 1994

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; generic 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)(viii).

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).

1. 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.

2. Withdrawal Time

   As specified in 21 CFR § 558.550(b)(1)(viii), a 5-day withdrawal time is required for the combination of bacitracin zinc, roxarsone and salinomycin.

3. 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.

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.

V. ATTACHMENTS:

Facsimile generic labeling and currently approved pioneer labeling are available:

1. Blue Bird label for the generic Type C medicated feed for broiler chickens
2. Blue Bird label for the pioneer Type C medicated feed for broiler chickens

Copies of these labels may be obtained by writing to the:

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855