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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-092 Sacox, Stafac - original approval

Approval Date: April 6, 1994

I. GENERAL INFORMATION:

NADA200-092
Sponsor:Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258
Generic Name:salinomycin sodium, virginiamycin
Trade Name:Sacox, Stafac
Marketing Status:Over the Counter (OTC)
  1. Dosage Form: Type A medicated articles NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (Sacox and Stafac) in Type C medicated feeds, rather than a premix incorporating both of these compounds.
  2. How Supplied:

    • Salinomycin sodium: 50-lb bags
    • Virginiamycin: 50-lb bags
  3. How Dispensed: OTC
  4. Label Claim of Amount of Active Ingredient(s):

    • Salinomycin sodium: 30 g/lb of Type A medicated article
    • Virginiamycin: 10, 20, 50 and 227 g/lb of Type A medicated article
  5. Route of Administration:

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

  6. Labeled Dosage:

    • Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066%)
      Virginiamycin: 5 g/ton (0.00055%)
      [21 CFR § 558.550(b)(1)(x)]
    • Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066%)
      Virginiamycin: 5 to 15 g/ton (0.00055-0.00165%)
      [21 CFR § 558.550 (b)(1)(xi)]
  7. Species: Broiler Chickens
  8. 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 for improved feed efficiency.
      [21 CFR § 558.550 (b)(1)(x)]
    • 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.
      [21 CFR § 558.550 (b)(1)(xi)]
  9. Generic Product:

    • Sacox
      Salinomycin sodium
      ANADA 200-075
      Hoechst-Roussel Agri-Vet Company
  10. Pioneer Product/ "Listed" Product:

    • Bio-Cox
      Salinomycin sodium
      NADA 128-686
      Agri-Bio Corporation
    • Stafac
      Virginiamycin
      NADA 091-467
      SmithKline Beecham Animal Health
    • Bio-Cox/Stafac
      Salinomycin sodium/virginiamycin
      NADA 138-828
      SmithKline Beecham Animal Health

 

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; generic salinomycin sodium), Hoechst-Roussel Agri-Vet Company is entitled to the approval of generic salinomycin in combination with virginiamycin. Bioequivalence studies are not required for the approval of this genetic combination (Type C medicated feed). Salinomycin sodium is codified under 21 CFR § 558.550. Virginiamycin is codified under 21 CFR § 558.63 5. The combination of salinomycin sodium and virginiamycin is codified under 21 CFR § 558.550(a) and (b)(1)(x) and (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 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 negligible residues of virginiamycin in edible broiler chicken tissues are established at 0.5 ppm in kidney, 0.3 ppm in liver, 0.2 ppm in skin/fat, and 0.1 ppm in muscle (21 CFR § 556.750).

Withdrawal Time
As provided in 21 CFR § 558.550(b)(1)(x) and (xi), a 0-day withdrawal time is required for the combination of virginiamycin and salinomycin.

Regulatory Method for Residues
Regulatory methods for salinomycin and virginiamycin were not required because residue levels in all broiler tissues (kidney, muscle, liver, and skin/fat) were significantly below the established safe concentration for total residues.

 

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 and virginiamycin, 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

  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