I. GENERAL INFORMATION:

NADA	141-059
Sponsor:	ALPHARMA, Inc. One Executive Drive Fort Lee, New Jersey 07024
Generic Name:	bacitracin methylene disalicylate chlortetracycline
Trade Name:	BMD®10, BMD®25, BMD®30, BMD®40, BMD®50, BMD®60 or BMD®75; and CTC®50, CTC®65, or CTC®70
Marketing Status:	Over-the-counter
Effect of Supplement:	This supplemental approval provides for using currently approved, single ingredient, Type A medicated articles in making combination drug Type B medicated swine feeds containing bacitracin methylene disalicylate and chlortetracycline.

 

II. INDICATIONS FOR USE

Bacitracin methylene disalicylate Type A Medicated Articles (NADA 46-592): For increased rate of weight gain and improved feed efficiency.

Chlortetracycline Type A Medicated Articles (NADA 46-699): For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.

III. DOSAGE

A.	DOSAGE FORM	This NADA provides for the combined use of two Type A Medicated Articles, bacitracin methylene disalicylate as per 21 CFR 558.76 and chlortetracycline as per 21 CFR 558.128 (a)(3). Bacitracin methylene disalicylate is supplied as a Type A Medicated Article in concentrations of 10, 25, 30, 40, 50, 60, or 75 grams of bacitracin activity per pound. Chlortetracycline is supplied as a Type A Medicated Article in concentrations of 50, 65, or 70 grams of chlortetracycline per pound.
B.	ROUTE OF ADMINISTRATION	Oral, in feed.
C.	RECOMMENDED DOSAGES:	Ten pounds of Type B medicated feeds are mixed with non-medicated feed ingredients to manufacture one ton of Type C medicated feed containing 10 to 30 grams bacitracin methylene disalicylate per ton and approximately 400 grams chlortetracycline per ton, varying with body weight and feed consumption to provide 10 mg/lb body weight daily. Feed for not more than 14 days.

IV. EFFECTIVENESS

As discussed in the Freedom of Information (FOI) Summary for the original approval of NADA 141-059 dated September 18, 1996.

VI. ANIMAL SAFETY

As discussed in the FOI Summary for the original approval of NADA 141-059 dated September 18, 1996.

VI. HUMAN SAFETY

As discussed in the FOI Summary for the original approval of NADA 141-059 dated September 18, 1996.

VII. AGENCY CONCLUSIONS

The approved NADA 46-592 for bacitracin methylene disalicylate in feed and
NADA46-699 for chlortetracycline in feed contain adequate data to establish the safety and effectiveness of each drug for swine. The data submitted in support of this supplemental NADA for the combination use of these drugs satisfies the requirements of Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA) and Part 514 of the implementing regulations for use in combination. The data demonstrate that the currently approved, single ingredient, bacitracin methylene disalicylate and chlortetracycline Type A medicated articles, when combined to produce Type B medicated feeds and when fed to swine under its labeled conditions of use, are safe and effective.

Proper use by lay persons can be expected because the directions are clearly written and there is reasonable certainty that the conditions of use, including mixing directions on the label, can and will be followed by the producer. The agency has concluded that this product shall continue to have over-the-counter marketing status.

According to 21 CFR 514.106(b)(2)(ii), this is a Category II supplement. The approval of this change is not expected to have any adverse effect on the safety and effectiveness of this new animal drug. Accordingly, this approval did not require a reevaluation of the safety and effectiveness data in the parent application.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

VIII. APPROVED PRODUCT LABELING

Copies of the draft facsimile labeling are attached to this document:

CTC/BMD® Type B Medicated Feed Bluebird Labels (2)

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