Source: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118307.htm
Timestamp: 2016-02-14 14:52:42
Document Index: 607878444

Matched Legal Cases: ['§ 558', '§ 558', '§ 558', '§ 558', '§ 556', '§ 556', '§ 558']

ANADA 200-143 Sacox, 3-Nitro, Baciferm - original approval Skip to main page content
ANADA 200-143 Sacox, 3-Nitro, Baciferm - original approval
salinomycin sodium, roxarsone , bacitracin zinc
Sacox, 3-Nitro, Baciferm
Established Name: Salinomycin sodium, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Bacitracin zinc
Trade/Proprietary Name: Sacox, 3-Nitro, Baciferm
NOTE: This ANADA provides for the combined use of three approved Type A medicated articles (Sacox, 3-Nitro and Baciferm) in Type C medicated feeds, rather than a premix incorporating all of these compounds.
Bacitracin zinc: 50-lb bags
Roxarsone: 10, 20, and 50 % roxarsone in Type A medicated article
Bacitracin zinc: 10, 25, 40 and 50 g/lb of Type A medicated article
Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066 %)
Roxarsone: 34.1 g/ton (0.00375 %)
Bacitracin zinc: 10 to 50 g/ton (0.00011-0.0055 %)
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 improved feed efficiency.
Roxarsone (3-nitro-4-hydroxyphenylarsonic acid);
NADA 007-891
NADA 046-920
Bio-Cox/3-Nitro/Baciferm
Salinomycin sodium/Roxarsone/Bacitracin zinc
NADA 139-190
Date of Approval: 04/22/94
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; genetic salinomycin sodium), Hoechst-Roussel Agri-Vet Company is entitled to the approval of generic salinomycin in combination with roxarsone and bacitracin zinc. 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. Bacitracin zinc is codified under 21 CFR § 558.78. Roxarsone (3-Nitro) is codified under 21 CFR § 558.530. The combination of salinomycin sodium, bacitracin zinc and roxarsone is codified under 21 CFR § 558.550(a) and (b)(1)(ix).
Tolerances for residues of bacitracin from bacitracin zinc are established at 0.5 ppm negligible residues in uncooked edible tissues of chickens (21 CFR § 556.70).
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.
As specified in 21 CFR § 558.550(b)(1)(ix), a 5-day withdrawal time is required for the combination of bacitracin zinc, roxarsone and salinomycin.
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 bacitracin residues. The method entitled "Modified Microbiological Method for Determination of Bacitracin in Tissues" 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 titled "Arsenic (Total) Residues in Animal Tissues, Spectrophotometric Method" published in AOAC, 14th Edition 41.009, page 777.
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, bacitracin zinc and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications. More in FOIA Drug Summaries