Approval Date: April 10, 1998

Freedom of Information Summary
NADA 046-666

I. GENERAL INFORMATION:

NADA	046-666
Sponsor:	Alpharma, Inc. One Executive Drive Fort Lee, NJ 07024
Generic Name:	Procaine G Penicillin Premix
Trade Name:	Procaine G Penicillin 50% Type A Medicated Article
Marketing Status:	Over the Counter (OTC)
Effect of Supplement:	This supplemental application provides for compliance with theconclusions of the National Academy of Science/National Research Council(NAS/NRC) evaluation of penicillin-containing Type A Medicated Articles.

II. INDICATIONS FOR USE

See below

III. DOSAGE:

A.	DOSAGE FORM	Medicated Feed
B.	ROUTE OF ADMINISTRATION	Oral in Medicated Type C feeds
C.	RECOMMENDED DOSAGES:
	CHICKENS, TURKEYS and PHEASANTS 2.4-50 grams/ton	For increased rate of weight gain and improved feed efficiency. WARNING: Do not feed to chickens or turkeys producing eggs for human consumption. Zero-day withdrawal period.
	QUAIL 5-20 grams/ton	For increased rate of weight gain and improved feed efficiency. WARNING: Zero-day withdrawal period.
	SWINE 10-50 g/t	For increased rate of weight gain and improved feed efficiency. WARNING: Zero-day withdrawal period.

IV. EFFECTIVENESS:

NADA 046-666 was originally approved as safe for use as labeled on January 1, 1971. The drug was the subject of National Academy of Sciences/National Research Council (NAS/NRC) reports which were published in the FEDERAL REGISTER of July 17, 1970 (35 FR 11706). The Academy evaluated these products as probably effective for faster gains and/or feed efficiency.

The Academy further stated that: (1) Claims for growth promotion or stimulation are disallowed and should be stated as "May result in faster gains and/or improved feed efficiency under appropriate conditions". (2) procaine penicillin G is probably effective for bloat protection in cattle, but its use should be limited to a 1-2 week period, and (3) each active ingredient in a preparation must contribute to the effectiveness of the preparation, therefore, additional documentation of the effect of silicone is required. (4) The appropriate claim for faster weight gains and improved feed efficiency should be :For increased rate of weight gain and improved feed effeciency for (under appropriate conditions of use)."

The Food and Drug Administration concurs with the Academy's finding. FDA proceeded to review all available data relating to the effectiveness of products subject to NADA 046-666 to determine which label claims were supported by the requisite proof of effectiveness. That review resulted in a letter to the sponsor dated September 23, 1992, in which the agency stated that it had concluded that such data supported effectiveness only for the increased rate of weight gain and improved feed efficiency in chickens, turkeys, pheasants, quail, and swine.

Thereafter, the sponsor complied with the evaluation of NAS/NRC and FDA's conclusions in the following manner:

1. Appropriate oral doses for all the allowable species and claims based on milligrams per pound of body weight are on the current labels.

2. Claims pertaining to bloat in cattle have been deleted from the labels.

3. Claims for growth promotion or stimulation have been removed. Allowable claims are for increased rate of weight gain and improved feed efficiency.

V. ANIMAL SAFETY:

The NADA 046-666 was originally approved as safe on January 1, 1971. No further safety data are required.

VI. HUMAN FOOD SAFETY:

The NAS/NRC evaluation of the drug is concerned only with the effectiveness and safety of the drug for the treated animal. FDA's approval of the supplemental application does not involve reevaluation or reaffirmation of the human food safety data in the parent application. The tolerances for residues of penicillin are codified at 21 CFR 556.510.

VII. AGENCY CONCLUSIONS:

This supplemental NADA satisfies the requirements of section 512 of the Act and demonstrates that Procaine G Penicillin 50% Type A Medicated Article when used under its proposed conditions of use, is safe and effective for the labeled indications. The approval provides for use of PROCAINE G PENICILLIN 50% TYPE A Medicated Article for the increased rate of weight gain and improved feed efficiency in chickens, turkeys, pheasants, quail and swine.

The "probably effective" finding of the NAS/NRC regarding procaine penicillin which was published in the FEDERAL REGISTER of July 17, 1970, was subsequently reviewed by FDA, resulting in the upgrade to "effective" status with respect to the claims noted in the previous paragraph. The firm submitted revised labeling to conform and, therefore, this supplemental NADA complies with the NAS/NRC evaluation and FDA's conclusions.

When NADA 046-666 was reviewed under NAS/NRC/DESI program, it was an over-the-counter product and this marketing status remains unchanged. Procaine G Penicillin 50%Type A Medicated Articles for use in food-producing animals are also currently on the market as over-the-counter products. Therefore, the Center for Veterinary Medicine has concluded that this product should retain over-the-counter marketing status.

Under the Center's supplemental approval policy (21 CFR 514.106(b)(2)), this is a Category ll change. The approval of this change is not expected to have any adverse effect on the safety or effectiveness of this new animal drug and, therefore, did not require a reevaluation of the human food or target animal safety data in the parent application.

VIII. LABELING (Attached)

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.