Approval Date: May 25, 1993
Freedom of Information Summary
NADA 200-038
I. GENERAL INFORMATION:
NADA 200-038 Sponsor: Agri Laboratories, Ltd.
P.O. Box 3103
St. Joseph, MO 64503Generic Name: sulfadimethoxine Trade Name: Sulfadimethoxine Injection 40% Marketing Status: Over the Counter (OTC) e. Dosage Form: injectable solution
f. How Supplied: 250 mL vials
g. How Dispensed: OTC
h. Amount of Active Ingredient: each mL contains 400 mg sulfadimethoxine
i. Route of Administration: intravenous injection only
j. Species: cattle
k. Labeled Dosage: 25 mg/lb (55 mg/kg) for the initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours.
l. Indications for Use:
Recommended in cattle for the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum , sensitive to sulfadimethoxine.
m. Pioneer Product: ALBON (sulfadimethoxine) Injection 40% NADA 041-245 by Hoffmann-LaRoche, Inc.
Date of Approval: May 25, 1993
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, Agri Laboratories, Ltd. was granted a waiver from conducting an in vivo bioequivalence study for sulfadimethoxine injection 40%. The generic and pioneer products are injectable solutions with the same active and inactive ingredients. The generic and pioneer products also contain the same concentration of active ingredient.
3. 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 (negligible residue) is established for sulfadimethoxine residues in the uncooked edible tissues of cattle under 21 CFR 556.640.
A tolerance of 0.01 ppm (negligible residue) is established for sulfadimethoxine residues in milk under 21 CFR 556.640.
Withdrawal Times
When a waiver of the in vivo bioequivalence study is granted, the generic product withdrawal times are those previously assigned to the pioneer product.
a Slaughter: 5 days in cattle
b. Milk Withholding:
Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food.
Regulatory Method:
The analytical method for the determination of sulfadimethoxine in tissues 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.
4. AGENCY CONCLUSIONS:
This ANADA satisfies the requirements of section 512 of the Act and demonstrates that sulfadimethoxine injectable solution, when used under its proposed conditions of use, is safe and effective for its labeled indications.
5. LABELING
1. Sulfadimethoxine injection 40% package insert
2. Sulfadimethoxine injection 40% shipper label
3. Sulfadimethoxine injection 40% carton labelCopies 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