Approval Date: April 6, 1994
I. GENERAL INFORMATION:
Hoechst-Roussel Agri-Vet Company
P. O. Box 2500
Somerville, New Jersey 08876-1258
salinomycin sodium, lincomycin
Over the Counter (OTC)
Label Claim of Amount of Active Ingredient(s):
- Salinomycin sodium 30 g/lb of Type A medicated article
- Lincomycin: 20 and 50 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).
Labeled Dosage: Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066%) Lincomycin: 2 to 4 g/ton (0.00022-0.00044%)
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 improved feed efficiency.
Generic Product: Sacox Salinomycin sodium ANADA 200-075 Hoechst-Roussel Agri-Vet Company
Pioneer Product/ "Listed" Product:
- Bio-Cox Salinomycin sodium NADA 128-686 Agri-Bio Corporation
- Lincomix Lincomycin NADA 034-085 The Upjohn Co.
- Bio-Cox/Lincomix Salinomycin sodium/Lincomycin NADA 137-537 Agri-Bio Corporation
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 lincomycin. 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. Lincomycin is codified under 21 CFR paragraph 558.325. The combination of salinomycin sodium and lincomycin is codified under 21 CFR paragraph 558.550(a) and (b)(1)(xiii).
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).
Tolerance/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 is not required (21 CFR paragraph 556.360).
As provided in 21 CFR paragraph 558.550 (b)(1)(xiii), a 0-day withdrawal time is required for the combination of lincomycin 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 lincomycin residues. The method entitled "Standard Operating Procedure for a Tissue Residue Study in Broiler Chickens Treated with Lincomycin, U-10, 149A" 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 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 and lincomycin, 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 attached, as shown:
- Blue Bird label for the generic Type C medicated feed for broiler chickens, and
- 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