Approval Date: December 31, 1992
I. GENERAL INFORMATION:
II. INDICATIONS FOR USE
P. O. Box 3103
St. Joseph, MO 64503
sulfadimethoxine 12.5% oral solution
Sulfadimethoxine 12.5% Oral Solution
Over the Counter (OTC)
Broiler and Replacement Chickens:
Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Meat Producing Turkeys:
Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera.
For Dairy Calves, Dairy Heifers and Beef Cattle:
Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
oral solution for drinking water or as a drench
ROUTE OF ADMINISTRATION
(Eds. note: The following table consists of 3 to 4 columns.)
|CHICKENS||0.05%||Add 1 fl oz* to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water
|TURKEYS||0.025%||Add 1 fl oz* to 4 gallons of drinking water or 25 fl oz to 100 gallons of drinking water|
** Stock Solution-To make 2 gallons of Stock Solution use:
1 gal Sulfadimethoxine 12.5% Drinking Water Solution
Concentrate - plus - 1 gal of water
2 qts Sulfadimethoxine 12.5% Drinking Water Solution
Concentrate - plus - 6 qts of water
TREATMENT PERIOD -- 5 consecutive days
SULFADIMETHOXINE IN WATER
AND BEEF CATTLE
|25 mg/lb first day followed by 12.5 mg/lb/day for 4 days.||1 gallon/***100 lb.b.w.||1 gallon/***150 lb.b.w.|
|FIRST DAY ADD:
||1 pint (16 fl oz) to:||25 gallons||16 gallons
|1 quart (32 fl oz) to:||50 gallons||33 gallons
|1 gallon (128 fl oz) to:||200 gallons||127 gallons
|NEXT 4 DAYS ADD:
||1 pint (16 fl oz) to:||50 gallons||33 gallons
|1 quart (32 fl oz) to:||100 gallons||66 gallons
|1 gallon (128 fl oz) to:||400 gallons||266 gallons
*** This dosage recommendation is based on water consumption of 1 gallon per 100 lb of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30-40%). Accordingly, adjustments in drug concentration in drinking water must be made to ensure proper drug intake. For individual treatment of cattle, Sulfadimethoxine 12.5% Drinking Water Solution may be given as a drench. Administer using same mg/lb dosage as outlined above. Four fluid ounces will medicate one-600 lb animal initially or two-600 lb animals on maintenance dose.
TREATMENT PERIOD -- 5 consecutive days
* 1 fl oz Sulfadimethoxine 12.5% Drinking Water Solution = 30 mL or 2 tablespoonfuls.
** Set proportioner to a feed rate of 1 fl oz of Sulfadimethoxine Stock Solution per gallon of water.
IV. & V. EFFECTIVENESS AND ANIMAL TARGET
Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, 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, AgriLabs, Ltd. was granted a waiver from conducting an in vivo bioequivalence study for sulfadimethoxine oral solution. The generic and pioneer products are oral solutions with the same active and inactive ingredients. The generic and pioneer products also contain the same concentration of active ingredient.
VI. HUMAN FOOD SAFETY:
Tolerance for the marker residue:
The tolerance established for the pioneer product applies to the generic product.
A tolerance of 0.1 ppm is established for sulfadimethoxine residues in the edible tissues of chickens, turkeys and cattle under 21 CFR 556.640.
When a waiver of the in vivo bioequivalence study is granted, the withdrawal times are the same as those previously assigned to the pioneer product.
For sulfadimethoxine 12.5% drinking water solution, a withdrawal period of five days has been established for chickens and turkeys, and a withdrawal period of seven days has been established for cattle.
The analytical method for the determination of sulfadimethoxine in tissue uses a thin layer-densitometric procedure. This method is found in the Official Methods of Analysis of the Association of Official Analytical Chemists, 15th edition, 1990.
VII. AGENCY CONCLUSIONS:
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that sulfadimethoxine oral solution, when used under its proposed conditions of use, is safe and effective for its labeled indications.
VIII. LABELING: (Attached)
- ALBON (sulfadimethoxine) 12.5% concentrated solution product label
- Sulfadimethoxine 12.5% Oral Solution product label
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.