Approval Date: November 29, 1995
I. GENERAL INFORMATION
Planalquimica Industrial Ltd.
Rua das Magnolias nr. 2405
Jardim das Bandeiras
Camphnas - Sao Paulo- Brazil
nicarbazin, bacitracin methylene disalicylate
Nicarmix 25, BMD
The subject of this FOI Summary is the combined use of two Type A medicated articles (Nicarmix 25 and BMD) in Type C medicated feeds.
- Nicarmix 25 (nicarbazin, ANADA 200-027, Planalquimica Industrial Ltda)
- BMD (bacitracin methylene disalicylate, NADA 46-592, A.L. Laboratories, Inc.)
How Dispensed: OTC
Pioneer Product: Nicarbazin + Bacitracin MD, Merck Research Labs, NADA 98-378
II. Indications For Use
As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis in broiler chickens and for increased rate of weight gain and improved feed efficiency.
III. Dosage Form, Route of Administration and Recommended Dosage
The two Type A Medicated Articles are supplied in 50 pound multi-wall bags at the following concentrations:
- Nicarmix 25 113.5 g nicarbazin/lb (25%)
- BMD 10, 25, 30, 40, 50, 60 or 75 g/lb bacitracin methylene disalicylate
The Type A Medicated Articles are intended for use in the manufacture of Type C Medicated feeds. The combination Type C Medicated chicken feed is to be manufactured at the following use levels:
- Nicannix 25 25% (113.5 g/ton)
- BMD 30 g/ton
IV. Target Animal Efficacy and 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, the generic sponsor is entitled to the approval of ANADA(s) for those combination Type C Medicated feeds (made using the generic Type A Medicated Article) for which the pioneer product sponsor holds NADA approvals. Bioequivalence studies are not required for the approval of this generic combination (Type C Medicated feed).
Nicarbazin is codified under 21 CFR § 558.366 and bacitracin methylene disalicylate 21 CFR § 558.76. The nicarbazin - BMD combination is also codified under 21 CFR § 558.366.
V. Human Safety
In accordance with FDA's Center for Veterinary Medicine'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 combination Type C Medicated feed.
Tolerance-Safe Concentrations of Residues
Nicarbazin - A tolerance of 4 ppm has been established for residues in uncooked chicken muscle, liver, skin, and kidney (21 CFR § 556.445). Nicarbazin is an equimolar complex of 4,4-dinitrocarbanilide (DNC) and 2-hydroxy-4,6-dimethylpyrimidine (HDP). The HDP portion of nicarbazin is excreted most rapidly from chickens, and DNC, the more persistent compound, serves as the marker residue. Liver is the target tissue.
BMD - Tolerances for residues of bacitracin from bacitracin methylene disalicylate are established at 0.5 ppm (0.02 unit per gram), negligible residue, in uncooked edible tissues of chickens (21 CFR § 556.70).
A 4 day withdrawal time is specified for the combination of nicarbazin and bacitracin methylene disalicylate.
Regulatory-Methods for Residues
The determinative assay for measuring residues in liver from chickens treated with nicarbazin is by high performance liquid chromatography (HPLC) with UV detection. The regulatory method is provided in the AOAC reference: Lewis, J.L, Macy, T.D., & Garteiz, D.A.(1989) I. Assoc. Off. Anal. Chem. 72, 577-581.
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 Place, Rockville, MD 20855.
VI. Agency Conclusions
This ANADA submitted under 512(b) of the Federal Food, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that Nicarbazin + Bacitracin methylene disalicylate, when used under its proposed conditions of use, is safe and effective for the labeled indications.
Attachments: The following generic and currently approved pioneer labeling are attached.
- Genetic Labeling (Planalquimica)
- Facsimile blue bird labeling for genetic product
- Pioneer Labeling (Merck)
- Facsimile blue bird labeling for pioneer
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855