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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-080 Sacox, 3-Nitro, Roxarsone, Flavomycin - original approval

Approval Date: March 8, 1994

I. GENERAL INFORMATION:

NADA200-080
Sponsor:Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258
Generic Name:Salinomycin sodium, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Bambermycins
Trade Name:Sacox, 3-Nitro, Roxarsone, Flavomycin
Marketing Status:Over the Counter (OTC)
  1. Established Name:

    Salinomycin sodium
    Roxarsone (3-nitro-4-hydroxyphenylarsonic acid; provided by A.L. Laboratories, Inc. or by
    Rhone-Poulenc, Inc.)
    Bambermycins

  2. Trade/Proprietary Name:

    Sacox
    3-Nitro (provided by A.L. Laboratories, Inc.) or
    Roxarsone (provided by Rhone-Poulene, Inc.)
    Flavomycin

  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/Roxarsone and Flavomycin) 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
    Bambermycins: 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 (3-Nitro; A.L. Laboratories, Inc.) or 10, 20 and 50% roxarsone in Type A medicated article (Roxarsone, Rhone-Poulenc, Inc.)
    Bambermycins: 2, 4, and 10 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: 45.4 g/ton (0.005%)
    Bambermycins: 1 to 2 g/ton (0.00011-0.0022%)

  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 improved feed efficiency.

  11. Genetic 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.

    Roxarsone
    Roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
    NADA 92-953
    Rhone-Poulenc, Inc.

    Flavomycin
    NADA 44-759
    Hoechst-Roussel Agri-Vet Company

    Bio-Cox/3-Nitro or Roxarsone/Flavomycin
    Salinomycin sodium/Roxarsone/Bambermycins
    NADA 134-185
    Agri-Bio Corporation

  13. Date of Approval: March 8, 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 genetic 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 bambermycins. 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. Bambermycins is codified under 21 CFR § 558.95. Roxarsone in this combination can be provided by A.L. Laboratories, Inc. or Rhone-Poulenc, Inc., as codified under 21 CFR § 558.530. The combination of salinomycin sodium, bambermycins and roxarsone is codified under 21 CFR § 558.95(b)(1)(xi).

 

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 genetic combination (Type C medicated feed).

  1. Tolerances for Residues
    The tolerance 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. Bambermycins has a no-tolerance clearance as published in 40 FR 59726 (December 30, 1975). The safe concentration for total bambermycins residues in the uncooked edible tissues of broiler chickens were established in NADA 44-759 (38 FR 1274; January 11, 1973).

    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
    Based on the information in 21 CFR § 558.95(b)(1)(xi), a 5-day withdrawal time is required for the combination of bambermycins, 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 bambermycins residues. The method entitled "Quantitative Agar Well Plate Assay of Bambermycins (Flavomycin) in Organs and Tissues" is on file at the Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish P1., 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, bambermycins, and roxarsone when used under its proposed conditions of use, is safe and effective for its labeled indications.

 

V. LABELING:

  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