Approval Date: April 6, 1994
Freedom of Information Summary
NADA 200-090
I. GENERAL INFORMATION:
NADA 200-090 Sponsor: Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), lincomycin Trade Name: Sacox, 3-Nitro, Lincomix Marketing Status: a. Established Name:
Salinomycin sodium
Roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
Lincomycinb. Trade/Proprietary Name:
Sacox
3-Nitro
Lincomixc. 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 Lincomix) in Type C medicated feeds, rather than a premix incorporating all of these compounds.
d. How Supplied:
Salinomycin sodium: 50-lb bags
Roxarsone: 50-lb bags
Lincomycin: 50-lb bagse. How Dispensed: OTC
f. 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
Lincomycin: 20 and 50 g/lb of Type A medicated articleg. Route of Administration:
These drugs are administered orally by adding the Type A medicated articles to complete, broiler feed (Type C medicated feed).
h. Labeled Dosage:
Salinomycin sodium: 40 to 60 g/ton
(0.0044-0.0066%)
Roxarsone: 34.1 g/ton (0.00375%)
Lincomycin: 2 g/ton (0.00022%)i. Species: Broiler Chickens
j. 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.
k. Generic Product:
Sacox
Salinomycin sodium
ANADA 200-075
Hoechst-Roussel Agri-Vet Companyl. Pioneer Product/"Listed" Product:
Bio-Cox
Salinomycin sodium
NADA 128-686
Agri-Bio Corporation3-Nitro
Roxarsone (3-nitro-4-hydroxyphenylarsonic acid);
NADA 7-8 91
A.L. Laboratories, Inc.Lincomix
Lincomycin
NADA 034-085
The Upjohn Co.Bio-Cox/3-Nitro/Lincomix
Salinomycin sodium/Roxarsone/Lincomycin
NADA 140-581
Agri-Bio Corporationm. Date of Approval: April 6, 1994
2. 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 Baciferm. 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. Lincomycin is codified under 21 CFR § 558.325. Roxarsone (3-Nitro) is codified under 21 CFR § 558.530. The combination of salinomycin sodium, lincomycin and roxarsone is codified under 21 CFR 558.550(a)(2) and (b)(1)(xiv).
3. 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 3 107), tissue residue studies are not required for the approval of this generic combination (Type C medicated feed).
a. 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 lincomycin in chickens are not required (21 CFR § 556.360).
Tolerances of arsenic (from roxarsone) are established at 0.5 ppm in muscle and 2 ppm in edible by-products (21 CFR § 556.60) with liver as the target tissue.
b. Withdrawal Time
As specified in 21 CFR § 558.550(b)(1)(xiv), a 5-day withdrawal time is required for the combination of lincomycin, roxarsone and salinomycin.
c. 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 lincomycin residues. The method entitled "Standard Operating Procedure for a Tissue Residue Study in Broiler Chickens Treated with Lincomycin, U-I0, 149A" 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.
4. 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, lincomycin and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.
5. 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