Approval Date: April 6, 1994
I. GENERAL INFORMATION:
Hoechst-Roussel Agri-Vet Company
P. O. Box 2500
Somerville, New Jersey 08876-1258
salinomycin sodium, roxarsone, virginiamycin
Sacox 3-Nitro Stafac
Over the Counter (OTC)
- 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.
- Stafac Virginiamycin NADA 091-467 SmithKline Beecham Animal Health
- Bio-Cox/3-Nitro/Stafac Salinomycin sodium/Roxarsone/ Virginiamycin NADA 138-953 SmithKline Beecham Animal Health
II. 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.
Type A medicated articles
NOTE: This ANADA provides for the combined use of three approved Type A medicated articles (Sacox, 3-Nitro and Stafac) in Type C medicated feeds, rather than a premix incorporating all of these compounds.
ROUTE OF ADMINISTRATION
These drugs are administered orally by adding the type A medicated articles to complete broiler feed (Type C medicated feed).
40 to 60 g/ton (0.0044-0.0066%)
45.4 g/ton (0.005%)
5 g/ton (0.00022%)
IV. & V. EFFECTIVENESS AND ANIMAL TARGET:
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 virginiamycin. Bioequivalence studies are not required for the approval of this generic combination (Type C medicated feed). Salinomycin sodium is codified under 21 CFR paragraph 558.550. Virginiamycin is codified under 21 CFR paragraph 558.635. Roxarsone (3-Nitro) is codified under 21 CFR paragraph 558.530. The combination of salinomycin sodium, virginiamycin and roxarsone is codified under 21 CFR paragraph 558.550(a) and (b)(1)(xii).
VI. 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 Concentration 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 virginiamycin in edible broiler chicken tissues are 0.5 in kidneys, 0.3 ppm in liver, 0.2 ppm in skin/fat, and 0.1 ppm in muscle (21 CFR paragraph 556.750).
Tolerances of arsenic (from roxarsone) are established at 0.5 ppm in muscle and 2 ppm in edible by-products (21 CFR paragraph 556.60) with liver as the target tissue.
As specified in 21 CFR paragraph 558.550 (b)(1)(xii), a 5-day withdrawal time is required for the combination of virginiamycin, roxarsone and salinomycin.
Regulatory Method for Residues
Regulatory methods for salinomycin and virginiamycin are 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.
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.
VII. 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, virginiamycin and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.
VIII. LABELING (Attached):
Facsimile generic labeling and currently approved pioneer labeling are attached, as shown:
- Blue Bird label for the generic Type C medicated feed for broiler chickens
- Blue Bird label for the pioneer Type C medicated feed for broiler chickens.
Copies of applicable labels may be obtained by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.