Approval Date: November 29, 1994
I. GENERAL INFORMATION:
Phoenix Scientific, Inc.
3915 S. 48th St. Terrace
P.O. Box 6457
St. Joseph, Missouri 64506-0457
Neomycin Oral Solution
Over the Counter (OTC)
II. INDICATIONS FOR USE
For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
ROUTE OF ADMINISTRATION
Orally in drinking water or milk
Administer to cattle (excluding veal calves), swine, sheep, and goats at a dose of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days
IV. & V. EFFECTIVENESS AND ANIMAL SAFETY:
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).
The generic product was the subject of an approved suitability petition (CP 92P-0363), in which the Agency granted permission to Phoenix Scientific, Inc., to file and ANADA for changes in the dosage form and in strength, relative to the pioneer product. The generic product if formulated as a solution, and the pioneer product if formulated as a water soluble powder. The generic product is formulated at 200 mg neomycin sulfate/mL, and the pioneer product if formulated at 325 g neomycin sulfate/pound of product. The pioneer and generic and generic products will be administered as oral solutions in water or milk, at a dosage of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days.
As a separate action, based upon the formulated characteristics of the pioneer and generic products, Phoenix Scientific, Inc., was granted a waiver form conducting an in vivo bioequivalence study. The pioneer and generic product does not contain any active ingredients that may significantly affect absorption of the active ingredient.
VI. HUMAN FOOD SAFETY:
The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.25 ppm is established for neomycin residues in the uncooked edible tissues of cattle, swine, sheep, and goats and a tolerance of 0.15 ppm is established for milk (21 CFR 556.430).
When a waiver of in vivo bioequivalence testing is granted, the withdrawal times are those previously assigned to the pioneer product.
The withdrawal times are 30 days for cattle (excluding veal calves) and goats and 20 days for swine and sheep (21 CFR 520.1485).
Regulatory Method for Residues
The regulatory analytical method for detection of residues of the drug is a microbiological test using Staphylococcus epidermidis suspension. The method is published by the Food and Drug Administration, "Antibiotic Residues in Milk, Dairy Products and Animal Tissues: Methods, Reports, and Protocols", revised October 1968, reprinted December 1974.
VI. AGENCY CONCLUSIONS:
This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that neomycin sulfate when used under the proposed conditions of use, is safe and effective for its labeled indications.
VIII. LABELING (Attached)
The following generic labeling and currently approved pioneer labeling are attached.
- Facsimile package label for NEOMYCIN ORAL SOLUTION for 473.1 mL (1 Pt), and 3.785 L (1 Gal).
- Approved pioneer package label for neomycin sulfate - Neomycin 325 Soluble Powder for 3.5 oz packages and 50 LB bags.
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.