Approval Date: August 3, 1998

Freedom of Information Summary
NADA 200-197

I. GENERAL INFORMATION:

NADA	200-197
Sponsor:	Contemporary Products, Inc. 3788 Elm Springs Road Springdale, Arkansas 72764-6067
Generic Name:	streptomycin sulfate 25% solution
Trade Name:	Streptomycin Oral Solution
Marketing Status:

Dosage Form: Oral Solution

How Supplied: 1 gallon containers

How Dispensed: OTC

Amount of Active

Ingredients: 250 mg streptomycin (as sulfate) per mL

Route of Administration: Oral, in the drinking water

Species: Chickens, swine and calves

Labeled Dosage: 1 to 2 tsp./2 gallons (10 to 15 mg/lb of body weight of steptomycin) of drinking water. See the following chart.

INDICATIONS AND TREATMENT

DISEASE	ACTION	DOSAGE
Chickens
Non-specific infectious enteritis in chickens.	Treatment of non-specific infectious enteritis caused by organisms susceptible to streptomycin sulfate.	(Based on a 2 lb chicken) 1 tsp/2 gal water = 10 mg streptomycin per pound of bodyweight. 1 1/2 tsp/2 gal water = 15 mg steptomycin per pound of bodyweight.
Swine and Calves
Bacterial enteritis in swine and calves	Treatment of bacterial enteritis caused by Escherichia coli and Salmonella spp. susceptible to streptomycin sulfate.	(Based on a 100 lb swine or 100 lb calf) 1 1/2 tsp/2 gal water = 10 mg streptomycin per pound of bodyweight. 11/2 tsp/2 gal water = 15 mg streptomycin per pound of bodyweight.

Indications for Use:

Chickens: For the treatment of non-specific infectious enteritis caused by organisms susceptible to streptomycin sulfate.

Swine and Calves: For the treatment of bacterial enteritis caused by Escherichia coli and Salmonella spp. susceptible to streptomycin sulfate.

Pioneer Product/ Strep Sol(NADA 65-252, Veterinary Services, Inc.)"Listed" Product:

 

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 bioeqivalence with the pioneer product to demonstrate target animal safety, drug effectiveness, and human safety.

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 (Fifth GADPTRA Policy Letter: 55 FR 24645, June 18, 1990; Bioequivalence Guidance: 61 FR 26182 - 26186, May 24, 1996).

Based upon the formulation characteristics of the generic product, Contemporary Products, Inc. was granted a waiver from conducting an in vivo bioequivalence study for Streptomycin Oral Solution. The generic and pioneer products contain the same active and inactive ingredients and are oral solutions.

3. HUMAN SAFETY:

Human Safety Relative to Food Consumption:

Tolerances are established for residues of streptomycin in uncooked, edible tissues of chickens, swine, and calves of 2.0 parts per million (ppm) in kidney and 0.5 ppm in other tissues. The established tolerances are set forth in 21 CFR 556.610.

Human Safety Relative to Possession, Handling, and Administration:

Labeling contains adequate caution/warning statements.

4. AGENCY CONCLUSIONS:

This ANADA submitted under section 512(b)(2) of the Federal Food, Drug and Cosmetic Act satisfies the requirements of section 512(n) of the Act and demonstrates that Streptomycin Oral Solution, when used under the proposed conditions of use, is safe and effective for the labeled indications.

Attachments:

1. Generic Labeling:

Bottle Label

2. Pioneer Labeling