Approval Date: March 18, 1994
I. GENERAL INFORMATION:
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258
salinomycin sodium, bacitracin methylene disalicylate
Over the Counter (OTC)
Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (Sacox and BMD) in Type C medicated feeds, rather than a premix incorporating both of these compounds.
Salinomycin sodium: 50-lb bags
Bacitracin methylene disalicylate: 50-lb bags
- How Dispensed: OTC
Label Claim of Amount of Active Ingredient(s):
Salinomycin sodium: 30 g/lb of Type A medicated article
Bacitracin methylene disalicylate: 30, 50, 60, and 75 g/lb of Type A medicated article
Route of Administration:
These drugs are administered orally by adding the Type A medicated articles to complete broiler feed (Type C medicated feed).
Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066 % )
Bacitracin methylene disalicylate: 4 to 30 g/ton (0.00044-0.0033 % )
[21 CFR § 558.550 (b)(1)(iii)]
Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066%)
Bacitracin methylene disalicylate: 4 to 50 g/ton (0.00044-0.0055 % )
[21 CFR § 558.550 (b)(1)(vi)]
- Species: Broiler Chickens
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 rate of weight gain and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(iii)]
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 improved feed efficiency. [21 CFR § 558.550 (b)(1)(vi)]
Hoechst-Roussel Agri-Vet Company
Pioneer Product/"Listed" Product:
Bacitracin methylene disalicylate
A.L. Laboratories, Inc.
Salinomycin sodium/Bacitracin methylene disalicylate
Date of Approval: March 18, 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 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 BMD. 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 methylene disalicylate is codified under 21 CFR § 558.76. The combination of salinomycin sodium and bacitracin methylene disalicylate is codified under 21 CFR § 558.550(a) and (b)(1)(iii) and (vi).
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 residues of bacitracin from bacitracin methylene disalicylate are established at 0.5 ppm negligible residues in uncooked edible tissues of chickens (21 CFR § 556.70).
- Withdrawal Time
As specified in 21 CFR § 558.550(b)(1)(iii) and (vi), a 0-day withdrawal time is required for the combination of bacitracin methylene disalicylate and salinomycin.
- 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 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.
IV. AGENCY CONCLUSIONS:
This ANADA submitted under section 512Co) 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 bacitracin methylene disalicylate, when used under its proposed conditions of use, is safe and effective for its labeled indications.
Facsimile generic labeling and currently approved pioneer labeling are available:
- 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 these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855