Approval Date: September 22, 1997
I. GENERAL INFORMATION
One Executive Drive
Fort Lee, New Jersey 07024
robenidine hydrochloride, bacitracin zinc
II. INDICATIONS FOR USE
As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima and E. necatrix; and, in the presence of 4 to 30 g/ton bacitracin zinc, for increased rate of weight gain; and, in the presence of 27 to 50 g/ton bacitracin zinc, for improved feed efficiency.
A. DOSAGE FORM: Type A medicated articles
NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (ROBENZ® and ALBAC®) in Type C medicated feeds, rather than a premix incorporating both of these compounds.
B. ROUTE OF ADMINISTRATION: These drugs are administered orally by adding the Type A medicated articles to complete turkey feed (Type C medicated feed).
C. RECOMMENDED DOSAGES:
- Robenidine HCl: 30 g/ton
- Bacitracin zinc: 4 to 50 g/ton
NOTES: Label Cautions Do not feed to laying chickens. Not for use in feeds for breeder chickens. Withdraw 5 days prior to slaughter. Type C feeds containing robenidine hydrochloride must be fed within 50 days from the date of manufacture.
IV. & V. 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 robenidine hydrochloride. 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. Robenidine hydrochloride is codified under 21 CFR §558.515. The combination of bacitracin zinc and robenidine hydrochloride is codified under 21 CFR §558.515 (d) (1) (vi).
VI. HUMAN SAFETY
Tolerances for the Marker Residue
The tolerances established for the pioneer bacitracin zinc product apply to the generic bacitracin zinc product.
The tolerances for residues of bacitracin from bacitracin zinc are established at 0.5 ppm (0.02 unit per gram), negligible residue, in uncooked edible tissues of chickens (21 CFR §556.70).
The tolerances for residues of robenidine hydrochloride are established at 0.2 ppm in skin and fat and 0.1 ppm (negligible residues) in edible tissues other than skin and fat of chickens (21 CFR §556.580)
Based on the information in 21 CFR §558.515(d)(1)(vi), a 5-day withdrawal time is required for the use of the combination of bacitracin with robenidine hydrochloride in chickens.
Regulatory Method for Residues
The regulatory analytical method for detection of residues of bacitracin is a microbiological test using Sarcina subflava (ATCC 7468) or Micrococcus subflavus (ATCC 10240). The method is found in Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports and Protocols, Revised October 1968, Reprinted December 1974, Nation Center for Antibiotic and Insulin Analysis, FDA, Washington, DC 20204
Modified Method for the Determination of Bacitracin in Tissues, Test Procedure Code 9A, AL Laboratories, One Executive Dr. PO Box 1399, Fort Lee NJ 07024.
The regulatory analytical method for robenidine hydrochloride is the polarographic method developed by American Cyanamid on file at the Center for Veterinary Medicine, Food and Drug Administration, HFV-199, 7500Standish Place, Rockville, Maryland 20855.
VII. 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 robenidine hydrochloride and bacitracin zinc, when used under its proposed conditions of use, is safe and effective for its labeled indications.
VIII. LABELING (Attached)
- Type C medicated Feed (Blue Bird) - Generic
Copies of applicable labels may be obtained by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.