Approval Date: Sept. 22, 1997
I. GENERAL INFORMATION
One Executive Drive
Fort Lee, New Jersey 07024
salinomycin, bacitracin zinc
A. Established Name:
- Bacitracin zinc
B. Trade/Proprietary Name:
C. Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (BIO-COX® and ALBAC® in Type C medicated feeds, rather than a premix incorporating both of these compounds.
D. How Supplied:
- Salinomycin: 50-lb bags
- Bacitracin zinc: 50-lb bags
E. How Dispensed: OTC
F. Label Claim of Amount of Active Ingredient(s):
- Salinomycin: 30 g/lb of salinomycin in Type A medicated article
- Bacitracin zinc: 50 g/lb bacitracin zinc in Type A medicated article
G. Route of Administration: These drugs are administered orally by adding the Type A medicated articles to complete chicken feed (Type C medicated feed).
H. Labeled Dosage:
- Salinomycin: 40 to 60 g/ton
- Bacitracin zinc: 10 to 50 g/ton
I. Species: Broiler chickens.
J. Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati, and for increased rate of weight gain.
K. Feeding Directions Feed continuously as the sole ration.
L. Label Cautions Do not feed to laying chickens. Not for use in feeds for breeder chickens. May be fatal if fed to adult turkeys or to horses. Not approved for use with pellet binders.
M. Generic Product:
N. Pioneer Product/"Listed" Product:
Hoffmann-La Roche, Inc.
II. EFFECTIVENESS AND TARGET ANIMAL SAFETY
In accordance with the Center for Veterinary Medicine'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 200-223, generic bacitracin zinc), ALPHARMA, Inc., is entitled to the approval of generic bacitracin zinc in combination with salinomycin. Bioequivalence studies are not required for the approval of this generic combination (Type C Medicated feed). Bacitracin zinc is codified under 21 CFR §558.78. Salinomycin is codified under 21 CFR §558.550. The combination of bacitracin zinc and salinomycin is codified under 21 CFR §558.550 (b) (1) (vii).
III. HUMAN SAFETY
a. Tolerances for the Marker Residue