Approval Date: April 22, 1994

Freedom of Information Summary
NADA 200-146

I. GENERAL INFORMATION:

NADA 200-146
Sponsor:

Phoenix Scientific, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTETRACYCLINE HCL SOLUBLE POWDER
Marketing Status:

FOI Summary; NADA 200-146 (original); OXYTETRACYCLINE HCL SOLUBLE POWDER (oxytetracycline hydrochloride); April 22, 1994
--Editor's abstract

 

a. Established Name: oxytetracycline hydrochloride

b. Trade Name/Proprietary Name: OXYTETRACYCLINE HCL SOLUBLE POWDER

c. Dosage Form: Soluble Powder for drinking water

d. How Supplied:

OXYTETRACYCLINE HCL SOLUBLE POWDER 50 grams of OTC HCl is supplied in 907.2 grams (2 lb) of product in a bucket container.

e. How Dispensed: OTC

f. Amount of Active Ingredients:

Each gram contains oxytetracycline hydrochloride equivalent to 55 mg oxytetracycline hydrochloride

g. Species: Chickens, Turkeys, Cattle, Swine, Sheep

h. Labeled Dosage And Indications:

(Refer to attached labeling for additional details on mixing instructions)

i. Pioneer Product "Listed" Product: Terramycin® Soluble Powder, NADA 008-622

j. Date of Approval: December 7, 1995

2. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS:

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. 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.)

Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver from conducting an in vivo bioequivalence study for OXYTETRACYCLINE HCL SOLUBLE POWDER. The generic and pioneer products are water soluble powders with the same active ingredients and no differences in the inactive ingredients which would affect absorption of the active ingredients.

3. HUMAN FOOD SAFETY

Tolerance

The tolerances established for the pioneer product apply to the generic product. Tolerances of 3 ppm in uncooked kidney and 1 ppm in uncooked muscle, liver, fat, and skin are established for residues of oxytetracycline in chickens and turkeys under 21 CFR 556.500(a). A tolerance of 0.1 ppm in uncooked edible tissues is established for residues of oxytetracycline in swine [21 CFR 556.500(b)], cattle, beef calves, nonlactating dairy cattle [21 CFR 556.500(c)], and sheep [21 CFR 556.500(e)].

Withdrawal Time:

When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal times are those previously assigned to the pioneer product.

For oxytetracycline hydrochloride, [21 CFR 520.1660d], do not administer to turkeys, swine, cattle, or sheep within 5 days of slaughter. Do not administer to chickens or turkeys producing eggs for human consumption.

Regulatory Method:

The analytical method for the determination of oxytetracycline hydrochloride in tissues uses a microbiological assay procedure. This method is found in the Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports, and Protocols , revised October 1968, reprinted December 1974, National Center for Antibiotic and Insulin Analysis, FDA, Washington, D.C. 20204.

4. 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 Oxytetracycline HCl Soluble Powder, when used under its proposed conditions of use, is safe and effective for the labeled indications.

5. ATTACHMENTS:

The following generic labeling and currently approved pioneer labeling are attached.

Generic Labeling

1. Facsimile package labeling for generic product

Pioneer Labeling

2. Pioneer package labeling for Terramycin® Soluble Powder

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