Approval Date: March 24, 1997
I. GENERAL INFORMATION
Phoenix Scientific, Inc
3915 South 48th Street Terrace
P.O. Box 6457
St. Joseph, MO 64506-0457
Sulfadimethoxine 12.5% Oral Solution
Dosage Form: Oral Solution
How Supplied: 3.785L (1 gal) multiple dose bottle
How Dispensed: OTC
Amount of Active Ingredients: Each mL contains 125 mg of Sulfadimethoxine (base)
Route of Administration: Oral in drinking water
Species: Chickens, Turkeys and Dairy Calves, Dairy Heifers and Beef Cattle
Labeled Dosage/Indications for use: Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Concentration: 0.05%. 1 fl oz to 2 gallons of drinking water.
Meat-Producing Turkeys- Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.
Concentration: 0.025%. 1 fl oz to 4 gallons of drinking water.
Indications for Use: Dairy Calves, Dairy Heifers and Beef Cattle- Use for the treatment of shipping fever complex, and bacterial pneumonia associated with Pasteurella Spp. sensitive to sulfadimethoxine; and calf diptheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Dosage: 25 mg/lb first day followed by 12.5 mg/lb for 4 days. (As drinking water or drench)
Pharmacological Category: Antibacterial
Pioneer Product: Albon® 12.5% Concentrated Solution manufactured by Hoffmann-La Roche (NADA 031-205)
II. 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).
For certain dosage forms, the agency grants a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990: fifth GADPTRA Policy Letter). In lieu of in vivo bioequivalence testing, the bioequivalence of the generic product to the pioneer product is based on the demonstrated chemical equivalence to the pioneer product.
Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver January 11, 1996 from conducting an in vivo bioequivalence study with Sulfadimethoxine 12.5% Oral Solution. The generic and pioneer products are solutions with the same active and inactive ingredients in the same concentrations.
III. HUMAN FOOD SAFETY
The tolerances established for the pioneer product apply to the generic product. Tolerances are established for residues of sulfadimethoxine in uncooked edible tissues of chickens, turkeys, and cattle as follows: 0.1 part per million (negligible residue). In milk at 0.01 part per million (negligible residue)(21 CFR 556.640).
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 sulfadimethoxine 12.5% Oral Solution is established under:
- 21 CFR 520.2220a(e)(1)(iii) Broiler and Replacement Chickens- 5 days before slaughter.
- 21 CFR 520.2220a(e)(2)(iii) Meat-Producing Turkeys- 5 days before slaughter
- 21 CFR 520.2220a(e)(3)(iii) Dairy Calves, Dairy Heifers and Beef Cattle- 7 days before slaughter.
Regulatory Method for Residues
No new method required for this approval.
Human Safety Relative to Possession, Handling and Administration
Labeling contains adequate caution/warning statements.
IV. AGENCY CONCLUSIONS
This is an Abbreviated New Animal Drug Application (ANADA) filed under Section 512(b)(2) of the Federal, Food, Drug and Cosmetic (FFD&C) Act.
Bioequivalence of this generic animal drug, Sulfadimethoxine 12.5% Oral Solution, was established by demonstration of chemical equivalence to the pioneer product, Hoffmann-La Roche's Albon® 12.5% Concentrated Solution (NADA 31-205)
This generic product and the pioneer product have identical labeling indications for the gallon bottle for use in chickens, turkeys and cattle. The route and method of administration of the two drugs are identical. Both drugs are administered orally in the drinking water. The generic and pioneer products contain the same active and inactive ingredients. Therefore, in compliance with FDA policy promulgated to implement section 512(b)(2) of FFD&C Act, no additional safety, efficacy, or in vivo bioequivalency studies were necessary or required.
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that Sulfadimethoxine 12.5% Oral Solution, is safe and effective for its labeled indications when used under its proposed conditions of use.
- Generic Labeling:
- 3.785 L (1 Gal) container label
- Pioneer Labeling:
- 1 gallon (128 fl oz) container label
Copies of applicable labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855