Approval Date: April 6, 1994
Freedom of Information Summary
NADA 200-097
I. GENERAL INFORMATION:
NADA 200-097 Sponsor: Hoechst-Roussel Agri Vet Company
P. O. Box 2500
Somerville, New Jersey 08876-1258Generic Name: salinomycin sodium, roxarsone Trade Name: Sacox 3-Nitro Marketing Status: 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 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 roxarsone. 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. Roxarsone (3-Nitro) is codified under 21 CFR paragraph 558.530. The combination of salinomycin sodium and roxarsone is codified under 21 CFR paragraph 558.550(a) and (b)(1)(v).
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 3107), 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 of arsenic (from roxarsone) are established at 0.5 ppm in muscle and 2 ppm in edible by-product (21 CFR paragraph 556.60) with liver as the target tissue.
b. Withdrawal Time
As specified in 21 CFR paragraph 558.550(b)(1)(v), 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 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 and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.
5. Labeling:
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
--- 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