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FOI Summary; NADA 200-068 (original); Oxytetracycline Hydrochloride (Oxytetracycline Hydrochloride); July 31, 1995
--Editor's abstract

1. GENERAL INFORMATION

ANADA: 200-068

ANADA/GENERIC SPONSOR:

 

Phoenix Pharmaceutical, Inc.
4621 Easton Rd.
St. Joseph, MO 64506-0457

 

A. Established Name: Oxytetracycline Hydrochloride

B. Trade/Proprietary Name: OXYTETRACYCLINE Hydrochloride Injection

C. Dosage Form: Injectable Solution

D. How Supplied: OXYTETRACYCLINE HCL SOLUTION 500 mL bottle

E. How Dispensed: OTC

F. Amount of Active Ingredients: 100 mg Oxytetracycline HCl per mL of solution

G. Species: Beef cattle, beef calves, non-lactating dairy cattle, and dairy calves

H. Labeled Dosage and Administration:

3-5 mg/lb body weight per day for a maximum of 4 consecutive days, administer only intravenously

I. Pharmacological Category: Antibiotic

J. Indications for Use:

OXYTETRACYCLINE HCL INJECTABLE SOLUTION is for treatment of:

Pasteurella spp. -- Bacterial pneumonia and shipping fever complex associated with Pasteurella spp.

Escherichia coli -- Bacterial enteritis (scours)

Spherophorous necrophorus -- Necrotic pododermatitis (foot rot), calf diphtheria

Actinobacillus lignierseii -- Wooden tongue

Wound infection,acute metritis,traumatic injury -- caused by oxytetracycline susceptible strains of streptococcal and staphylococcal bacteria

K. Pioneer/NADA #: Fermenta's MEDAMYCIN ®-100, NADA 108-963.

L. Date of Approval: July 31, 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. 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).

Based upon the formulation characteristics of the generic product, Phoenix Pharmaceutical, Inc., was granted a waiver from conducting an in vivo bioequivalence study for OXYTETRACYCLINE HYDROCHLORIDE. The generic and pioneer products contain the same active and inactive ingredients and are injectable solutions.

3. HUMAN FOOD SAFETY:

Tolerance

The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.1 ppm is established for the uncooked edible tissues of beef cattle, beef calves, non-lactating dairy cattle, and dairy calves (21CFR556.500(c)).

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. The withdrawal time for oxytetracycline HCl injectable solution is established under 21 CFR 522.1662a: 22 days for cattle. Not for use in lactating dairy cattle.

Regulatory Method for Residues

The analytical method for the detection of residues of oxytetracycline is a microbiological test using Bacillus cereus var. mycoides . This method may be found in 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, DC 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 hydrochloride when used under the proposed conditions of use, is safe and effective for its labeled indications.

5. ATTACHMENTS:

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

Generic labels:

1. Phoenix 500 mL bottle
2. Phoenix Insert

Pioneer labels:

3. Medamycin®-100 500 mL bottle
4. Medamycin®-100 Insert

6. LABELING

1. Oxytetracycline hydorchloride injections 100mg/mL bottle label
2. Oxytetracycline hydorchloride injections 100mg/mL package insert
3. Medamycin®-100 bottle label
4. Medamycin®-100 package insert

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