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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-091 Sacox and 3-Nitro and Aureomycin - original approval

Approval Date: November 25, 1994

I. GENERAL INFORMATION:

NADA200-091
Sponsor:Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258
Generic Name:salinomycin sodium/chlortetracycline calcium complex/roxarsone
Trade Name:Sacox and 3-Nitro and Aureomycin
Marketing Status:Over the Counter (OTC)
  1. Established Name: Salinomycin sodium/chlortetracycline calcium complex/roxarsone
  2. Trade/Proprietary Name:

    • Sacox
    • 3-Nitro
    • Aureomycin
  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 Aureomycin) in Type C medicated feeds, rather than a premix incorporating all three of these compounds.

  4. How Supplied:

    • Salinomycin sodium: 50-lb bags
    • Chlortetracycline (CTC): 50-lb bags
    • Roxarsone: 50-lb bags
  5. How Dispensed: OTC
  6. Label Claim of Amount of Active Ingredient(s):

    • Salinomycin: 30 g/lb in Type A medicated article
    • CTC: 50, 70, and 100 g/lb in Type A medicated article
    • Roxarsone: 10, 20, and 50% (45.4, 90.8, 227 g/lb) in 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 Blue Bird Labeling:

    Salinomycin sodium activity 40 to 60 grams per ton (.0044-.0066%) Chlortetracycline calcium complex equivalent to chlortetracycline HCl 500 grams per ton (.055%) 3-Nitro Roxarsone 45.4 grams per ton (.005%)

  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 as an aid in the reduction of mortality due to E. coliinfections susceptible to such treatment.

  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.
    • Aureomycin
      Chlortetracycline calcium complex
      NADA 48-761
      American Cyanamid Company
    • Aureomycin+Biocox+3 Nitro
      Chlortetracycline calcium complex, Roxarsone, Salinomycin sodium
      NADA 140-867
      American Cyanamid Company
  13. Date of Approval: November 25, 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 chlortetracycline. 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. Roxarsone is codified under 21 CFR 558.530. Chlortetracycline is codified under 21 CFR 558.128. The combination of salinomycin sodium, roxarsone, and chlortetracycline is codified under 21 CFR 558.550(b)(1)(xv).

III. HUMAN FOOD SAFETY:

Tolerances and Safe Concentration for the Marker Residue
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 chlortetracycline are established at 1.0 ppm in the uncooked muscle, liver, fat, and skin and 4.0 ppm in uncooked kidney of broiler chickens (21 CFR 556.150).

Tolerances of arsenic (from roxarsone) are established at 0.5 ppm in uncooked muscle and 2 ppm in uncooked edible by-products of broiler chickens with liver as the target tissue (21 CFR 556.60).

Withdrawal Time
Based on the information in 21 CFR 558.550(b)(1)(xv), a 5-day withdrawal time is required for the combination of salinomycin, chlortetracycline, and roxarsone.

Regulatory Method for Residues
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 regulatory analytical method for the determination of residue of chlortetracycline is a microbiological test using Bacillus cereusvar. mycoides(ATCC 11778). The method is published by the Food and Drug Administration, "Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports, and Protocols", revised October 1968, Reprinted December 1974.

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 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 512(n) of the Act and demonstrates that the combination of salinomycin sodium, chlortetracycline calcium complex, and roxarsone, when used under the 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