Approval Date: April 6, 1994
Freedom of Information Summary
NADA 200-089
I. GENERAL INFORMATION:
NADA 200-089 Sponsor: Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258Generic Name: salinomycin sodium, bacitracin zinc Trade Name: Sacox, Baciferm Marketing Status: Over the Counter (OTC) a. Established Name:
Salinomycin sodium
Bacitracin zincb. Trade/Proprietary Name:
Sacox
Bacifermc. Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (Sacox and Baciferm) in Type C medicated feeds, rather than a premix incorporating both of these compounds.
d. How Supplied:
Salinomycin sodium: 50-lb bags
Bacitracin zinc: 50-lb bagse. How Dispensed: OTC
f. Label Claim of Amount of Active Ingredient(s):
Salinomycin sodium: 30 g/lb of Type A medicated article
Bacitracin zinc: 10, 25, 40 and 50 g/lb of Type A medicated articleg. Route of Administration:
These drugs are administered orally by adding the Type A medicated articles to complete broiler feed (Type C medicated feed).
h. Labeled Dosage:
Salinomycin sodium: 40 to 60 g/ton (0.0044-0.0066%)
Bacitracin zinc: 10 to 50 g/ton (0.0001-0.0055%)i. Species: Broiler Chickens
j. 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 increased rate of weight gain.
k. Generic Product:
Sacox
Salinomycin sodium
ANADA 200-075
Hoechst-Roussel Agri-Vet Companyl. Pioneer Product/"Listed" Product:
Bio-Cox
Salinomycin sodium
NADA 128-686
Agri-Bio CorporationBaciferm
Bacitracin zinc
NADA 046-920
American Cyanamid Co.Bio-Cox/Baciferm
Salinomycin sodium/Bacitracin zinc
NADA 139-235
American Cyanamid Co.m. Date of Approval: April 6, 1994
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 Baciferm. 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 zinc is codified under 21 CFR §558.78. The combination of salinomycin sodium, bacitracin zinc and roxarsone is codified under 21 CFR §558.550(a) and (b)(1)(vii).
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 for residues of bacitracin from bacitracin zinc are established at 0.5 ppm negligible residues in uncooked edible tissues of chickens (21 CFR §556.70).
b. Withdrawal Time
As provided in 21 CFR §558.550(b)(1)(vii), a 0-day withdrawal time is required for the combination of bacitracin zinc 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 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.
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 bacitracin zinc, when used under its proposed conditions of use, is safe and effective for its labeled indications.
5. ATTACHMENTS:
Facsimile generic labeling and currently approved pioneer labeling are available
1. Blue Bird label for the generic Type C medicated feed for broiler chickens
2. Blue Bird label for the pioneer Type C medicated feed for broiler chickensCopies 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