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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 096-298 Avatec® - supplemental approval (October 20, 1995)

I. GENERAL INFORMATION:

NADA096-298
Sponsor:Hoffmann-LaRoche, Inc.
340 Kingsland Road
Nutley, New Jersey 07110-1199
Generic Name:lasalocid sodium
Trade Name:Avatec®
Marketing Status:Over the Counter (OTC)
Effect of Supplement:This supplement adds an additional claim for the prevention of coccidiosis in young rabbits.

II. INDICATIONS FOR USE

For the prevention of coccidiosis in young rabbits caused by Eimeria stiedae.

III. DOSAGE:

A.DOSAGE FORM

Type A medicated article to be mixed with feed to produce a Type C medicated feed. The Type C medicated feed is formulated to provide 113 g lasalocid/ton to be fed as the sole ration for up to 6 and 1/2 weeks of age.

This FREEDOM OF INFORMATION SUMMARY references data in Public Master File (PMF) 5042, 55 FR 9771, March 15, 1990, in support of the supplemental new animal drug application for rabbits. The data were generated by:

Dr. Loyd T. Patterson
121 Dupree Circle
Rainesville, Alabama 35986

Dr. Robert D'Antonio
Dr. Milton April
Division of Veterinary Medical Research Center for Veterinary Medicine
Food and Drag Administration
Bldg. 3228-A Center Road Agricultural Research Center - East Beltsville, Maryland 20705

Dr. Alex McDonald
Hoffmann-LaRoche, Inc.
Nutley, New Jersey 07110

NRSP-7 (formerly IR-4 Project)
Southern Region
University of Florida
Gainesville, Florida 32610

B.ROUTE OF ADMINISTRATIONSee above
C.RECOMMENDED DOSAGES:See above

IV. EFFECTIVENESS:

Efficacy data from the FOI summary for PMF 5042, 55 FR 9771, March 15, 1990, demonstrated that a level of 113 g/ton (125 ppm) lasalocid sodium for up to 6 weeks in complete feed was efficacious based on reduction of mortality, oocyst numbers, liver size, or liver scores for the prevention of coccidiosis caused by Eimeria stiedae in rabbits.

V. ANIMAL SAFETY:

Target animal safety data from the FOI summary for PMF 5042, 55 FR 9771, March 15, 1990, demonstrated that administration of lasalocid sodium in feed has a reasonable margin of safety in rabbits. Lasalocid is safe to rabbits when used at the dosage level of 125 ppm (1x) in feed for up to six weeks.

VI. HUMAN FOOD SAFETY:

Toxicity Tests: Data regarding toxicity testing are contained in the approved NADA.

VII. AGENCY CONCLUSIONS:

The data submitted in support of this supplemental NADA comply with the requirements of section 512 of the Act and demonstrate that lasalocid sodium, when used under the proposed conditions of use, is safe and effective for the prevention of coccidiosis caused by Eimeria stiedae in rabbits.

Human food safety data which have been submitted under PMF 5042, 55 FR 9771, March 15, 1990, demonstrates that lasalocid will be used to treat coccidiosis which is a disease of young rabbits. The label will state that lasalocid should be fed continuously up to 6 and 1/2 weeks of age. As the rabbits are not slaughtered until the age of 8 to 12 weeks, there is an inherent withdrawal time of at least 10 days after administration. Based on this and the fact that lasalocid residue depletes from the liver (target organ) after 6 days, the Agency has concluded that a withdrawal period is not necessary.

The original approval of lasalocid sodium was as an over-the-counter drug. Accurate diagnosis of coccidiosis in rabbits, which is the new species to be added to the label, can be made with reasonable degree of certainty by the layman. Adequate directions for use have been written for the layman, and the conditions for use prescribed on the labeling are likely to be followed in practice. Therefore, the Center for Veterinary Medicine (CVM) has concluded that this product shall have over-the-counter marketing status.

Under the Center's supplemental approval policy 21 CFR 514.106(b)(2)(vii), this is a Category II change. The approval of this change did not require a reevaluation of the safety or effectiveness data in the parent application.

Under Section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act, this approval for food producing animals does not qualify for marketing exclusivity because the supplemental application does not contain reports of new clinical or field investigations (other than bioequivalence or residue studies) and new human food safety studies (other than bioequivalence or residue studies) essential to the approval and conducted or sponsored by the applicant.

VIII. LABELING (Attached)

Facsimile Type A medicated article labeling
Facsimile bluebird labeling for Type C medicated feed
Currently approved product labeling for Type A medicated article

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.