Approval Date: November 25, 1994
I. GENERAL INFORMATION:
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258
salinomycin sodium/chlortetracycline calcium complex
Sacox and Aureomycin
Over the Counter (OTC)
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 chlortetracycline. 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. Chlortetracycline is codified under 21 CFR 558.128. The combination of salinomycin sodium and chlortetracycline is codified under 21 CFR 558.550(a) and (b)(1)(xvi).
III. HUMAN FOOD SAFETY:
Tolerances and Safe Concentrations for the Marker Residue
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 chlortetracycline are established at 1.0 ppm in the uncooked muscle, liver, fat, and skin and 4.0 ppm in uncooked kidney of broiler chickens (21 CFR 556.150).
Based on the information in 21 CFR 558.550(b)(1)(xvi), a 24 hour withdrawal time is required for the combination of salinomycin and chlortetracycline.
Under NADA 128-686 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.
The regulatory analytical method for the determination of residue of chlortetracycline is a microbiological test using Bacillus cereus var. mycoides (ATCC 11778). The method is published by the Food and Drug Administration, "Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports, and Protocols", revised October 1968, Reprinted December 1974.
IV. AGENCY CONCLUSIONS:
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of 512(n) of the Act and demonstrates that the combination of salinomycin sodium and chlortetracycline calcium complex when used under the 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