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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 141-102 DECCOX®, BMD® - original approval

Approval Date: July 24, 1998

I. GENERAL INFORMATION:

NADA141-102
Sponsor:Alpharma Inc.
One Executive Drive
Fort Lee, NJ 07024
Generic Name:Decoquinate, Bacitracin methylene disalicylate
Trade Name:DECCOX®, BMD®
Marketing Status:Over the Counter (OTC)

 

II. INDICATIONS FOR USE:

For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti, and for increased rate of weight gain and improved feed efficiency in broiler chickens.

 

III. DOSAGE

A.DOSAGE FORMThis original NADA provides for the combined use of these two Type A medicated articles, decoquinate as per 21 CFR §558.195, and bacitracin methylene disalicylate as per 21 CFR §558.76.
Decoquinate is supplied as a Type A medicated article containing 6 percent decoquinate. Bacitracin methylene disalicylate is supplied as Type A medicated articles in concentrations of 10, 25, 30, 40, 50, 60, or 75 grams bacitracin activity per pound.
B.ROUTE OF ADMINISTRATIONOral, via the feed.
C.RECOMMENDED DOSAGES: 
 DecoquinateDecoquinate is added to broiler chicken feed at a concentration of 27.2 g/ton for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti.
 Bacitracin methylene disalicylateBacitracin methylene disalicylate is added to broiler chicken feed at concentrations from 4 to 50 g/ton for increased rate of weight gain and improved feed efficiency.

 

IV. EFFECTIVENESS:

In accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Animal Drug Availability Act of 1996, if the active ingredients or animal drugs intended for use in combination in animal feed have previously been separately approved for the particular uses and conditions of use for which they are intended for use in combination, FDA will not refuse to approve an NADA for the combination on effectiveness grounds unless the Agency finds that the NADA fails to demonstrate that 1) there is substantial evidence to demonstrate that any active ingredient or animal drug intended only for the same use as another active ingredient or animal drug in the combination makes a contribution to the labeled effectiveness, 2) each of the active ingredients or animal drugs intended for at least one use that is different from all other active ingredients or animal drugs used in the combination provides appropriate concurrent use for the intended target population, or 3) where the combination contains more than one nontopical antibacterial active ingredient or animal drug, there is substantial evidence that each of the nontopical antibacterial active ingredients or animal drugs makes a contribution to the labeled effectiveness (21 USC §512(d)(4)(D)).

Decoquinate, as provided by Alpharma Inc., has previously been separately approved for use in broiler chicken feed for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E acervulina, E. maxima, and E. brunetti (21 CFR §558.195 (d)).Bacitracin methylene disalicylate, as provided by Alpharma Inc., has previously been separately approved for use in broiler chicken feed for increased rate of weight gain and improved feed efficiency (21 CFR §558.76 (d)(1)(i)). Effectiveness for both drugs, decoquinate and bacitracin methylene disalicylate, when administered alone in accordance with its approved uses and conditions of use, is demonstrated in Alpharma Inc.’s approved NADAs 39-417 and 46-592, respectively.

Because decoquinate and bacitracin methylene disalicylate both have at least one use that is different from all other animal drugs used in the combination, the NADA must also demonstrate that decoquinate plus bacitracin methylene disalicylate provide appropriate concurrent use for the intended target population. The use of decoquinate plus bacitracin methylene disalicylate provides appropriate concurrent use because these drugs are intended to treat different conditions (decoquinate, coccidiosis; bacitracin methylene disalicylate, growth performance) likely to occur simultaneously with sufficient frequency in broiler chickens. There is no more than one nontopical antibacterial (bacitracin methylene disalicylate) contained in this combination animal drug intended for use in Type C medicated feed. Decoquinate is not considered to be an antibacterial animal drug for use in broiler chickens for the purposes of §512(d)(4) of the FFDCA, because decoquinate is approved only for prevention of a protozoal disease in broiler chickens.

 

V. ANIMAL SAFETY

In accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Animal Drug Availability Act of 1996, if the active ingredients or animal drugs intended for use in combination have previously been separately approved for the particular uses and conditions of use for which they are intended for use in combination, FDA will not refuse to approve an NADA for the combination on target animal safety grounds unless there is a substantiated scientific issue specific to an active ingredient or animal drug used in the combination or a scientific issue is raised by target animal observations contained in studies submitted to the NADA for the combination and FDA finds that the application fails to establish that such combination active ingredient or animal drug is safe for the target animal.

Decoquinate, as provided by Alpharma Inc., has previously been separately approved for use in broiler chicken feed for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E acervulina, E. maxima, and E. brunetti (21 CFR §558.195 (d)).Bacitracin methylene disalicylate, as provided by Alpharma Inc., has previously been separately approved for use in broiler chicken feed for increased rate of weight gain and improved feed efficiency (21 CFR §558.76 (d)(1)(i)). Target animal safety for each drug, decoquinate and bacitracin methylene disalicylate, when administered alone in accordance with its approved uses and conditions of use, is demonstrated in Alpharma Inc.’s approved NADAs 39-417 and 46-592, respectively. The Agency has found no substantiated scientific issue relating to the target animal safety of decoquinate or bacitracin methylene disalicylate when used in combination under this NADA and no scientific issue has been raised by target animal observations submitted as part of the NADA for this combination. Thus, pursuant to FFDCA, as amended by the Animal Drug Availability Act of 1996, no specific target animal safety study(ies) are required for approval of NADA 141-102.

 

VI. HUMAN SAFETY:

In accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Animal Drug Availability Act of 1996, if the active ingredients or animal drugs intended for use in combination have previously been separately approved for the particular uses and conditions of use for which they are intended for use in combination, FDA will not refuse to approve an NADA for the combination on target animal safety grounds unless one or more of the active ingredients or animal drugs used in the combination at the longest withdrawal for the respective active ingredients or animal drugs in the combination exceeds the established tolerance, or one or more active ingredients or animal drugs in the combination interferes with the method of analysis for another active ingredient or drug in the combination.

Safety for the approved products, decoquinate and bacitracin methylene disalicylate, has been established by data submitted to NADA 39-417 and 46-592, respectively.

A. Tolerances:

Tolerances for residues of decoquinate in uncooked edible tissues of chickens are at 2 ppm in tissues other than skeletal muscle and 1 ppm in skeletal muscle in 21 CFR §556.170. Tolerances for residues of bacitracin in uncooked edible tissues of chickens are established at 0.5 ppm (0.02 unit/g) in 21 CFR §556.70.

B. Residue Data:

Cobb broiler chickens were fed medicated feed containing 0.003% decoquinate, roxarsone at 45 g/ton, penicillin at 50 g/ton as procaine penicillin, and bacitracin at 50 g/ton as zinc bacitracin and were raised in floor pens for 61 days. All tissues of chickens killed at zero withdrawal of medication contained less than the established tolerance for decoquinate [muscle (range 0.22-0.40 ppm), skin-fat (range 0.88-1.18 ppm), liver (range 0.76-1.04 ppm), and kidney (range 0.92-0.86 ppm)]. There were no positive findings for bacitracin in any of the edible tissues taken at zero withdrawal. This study also provided data to show assay noninterference between bacitracin and decoquinate.

Substantial scientific information provided by Alpharma Inc. shows that the likelihood of other drugs in combination with bacitracin methylene disalicylate altering the bacitracin residues in tissues of animals is extremely improbable; there are no longer requirements for conducting studies demonstrating tissue residue and analytical method non-interference for Alpharma Inc.’s bacitracin methylene disalicylate where it is included at already approved levels. Such is the case for this combination. Data generated over many years show that residues of bacitracin methylene disalicylate are not detected, whether the drug is used alone or in combination.
Studies using radiolabeled drugs confirm that bacitracin is recovered mostly with the feces, with only small amounts of radioactivity associated with the urine.

The available residue chemistry information supports the assignment of a zero day withdrawal period for broiler chickens fed the combination of decoquinate (27.2 g/ton) and bacitracin methylene disalicylate (4-50 g/ton).

C. Regulatory Methods for Residues:

A fluorometric method is used to assay tissues for decoquinate. The method entitled "AOAC Official Method 973.79, Decoquinate Residues in Animal Tissues, Fluorometric Method" is published in the AOAC Official Methods of Analysis (1995), Chapter 23, p. 4.

A microbiological method is used to assay tissues for bacitracin residues. The method entitled "Modified Microbiological Method for Determination of Bacitracin in Tissues" is on display in the Food and Drug Administration’s Freedom of Information Publication Room, 5600 Fisher’s Lane, Rockville, MD 20857.

 

VII. AGENCY CONCLUSION:

The data submitted in support of this NADA comply with the requirements of Section 512 of the FFDCA and demonstrate that decoquinate (27.2 g/ton) plus bacitracin methylene disalicylate (4 to 50 g/ton) are safe and effective for the claims indicated in Section II of this FOI summary.

Pursuant to 21 CFR §514.106 (b)(2)(vi), this combination NADA approval is regarded as a Category II supplemental change which did not require a reevaluation of safety and efficacy data in the parent NADAs. The drugs are to be fed in Type C medicated feeds, in accordance with Sections II and III of the FOI Summary and the Blue Bird labeling that is attached to this document.

Residue data show that decoquinate is within the established safe concentrations in edible chicken tissues [muscle (range 0.22-0.40 ppm), skin-fat (range 0.88-1.18 ppm), liver (range 0.76-1.04 ppm), and kidney (0.92-0.86 ppm)]. Bacitracin was undetectable in any of the edible tissues assayed.

 

VIII. LABELING (Attached)

  1. Type C medicated Feed (Blue Bird).

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