Animal & Veterinary
ANADA 200-083 Sacox, Flavomycin - original approval
Approval Date: March 18, 1994
I. GENERAL INFORMATION:
|Sponsor:||Hoechst-Roussel Agri-Vet Company|
P.O. Box 2500
Somerville, New Jersey 08876-1258
|Generic Name:||salinomycin sodium, bambermycins|
|Trade Name:||Sacox, Flavomycin|
Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (Sacox and Flavomycin) in Type C medicated feeds, rather than a premix incorporating both of these compounds.
Salinomycin sodium: 50-lb bags
Bambermycins: 50-lb bags
- How Dispensed: OTC
Label Claim of Amount of Active Ingredient(s):
Salinomycin sodium: 30 g/lb of Type A medicated article
Bambermycins: 2, 4, and 10 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%)
Bambermycins: 1 to 3 g/ton (0.00011-0.00033%)
- 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.
Hoechst-Roussel Agri-Vet Company
Pioneer Product/"Listed" Product:
Hoechst-Roussel Agri-Vet Company
- 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 bambermycins. 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. Bambermycins is codified under 21 CFR § 558.95. The combination of salinomycin sodium and bambermycins is codified under 21 CFR § 558.95Co)(1)(xii).
III. HUMAN FOOD SAFETY:
In accordance with the Centers 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 for Residues
The tolerance 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.
Bambermycins has a no-tolerance clearance as published in 40 FR 59726 (December 30, 1975). The safe concentration for total bambermycins residues in the uncooked edible tissues of broiler chickens were established in NADA 44-759 (38 FR 1274; January 11, 1973).
- Withdrawal Time
Based on the information in 21 CFR § 558.95(b)(1)(xii), a 0-day withdrawal time is required for the combination ofbambermycins 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 bambermycins residues. The method entitled "Quantitative Agar Well Plate Assay of Bambermycins (Flavomycin) in Organs and 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 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 bambermycins 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