Approval Date: December 4, 1996
I. GENERAL INFORMATION
Fermenta Animal Health Company
P. O. Box 338
15th & Oak Streets
Elwood, Kansas 66024
sulfadimethoxine 12.5% oral solution
SDM Sulfadimethoxine 12.5% Oral Solution
TRADE NAME: SDM Sulfadimethoxine 12.5% Oral Solution
PIONEER PRODUCT: Albon®/Agribon® 12.5% Oral Solution (NADA 31-205) (Pfizer)
ESTABLISHED NAME: sulfadimethoxine 12.5% oral solution
HOW DISPENSED: OTC
COMPOSITION: Each fluid ounce contains 3.75 g sulfadimethoxine solubilized with sodium hydroxide.
DOSAGE FORM: Oral solution
SPECIES: Broiler and replacement chickens, meat producing turkeys, dairy calves and heifers, and beef cattle
UNIT CONTENT: Net contents: 1 gallon (3.785 liters)
- Chickens: Coccidiosis, fowl cholera, and coryza.
- Turkeys: Coccidiosis and fowl cholera.
- Cattle: Shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
DOSAGE (REFER TO ATTACHED LABELING)
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). 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 and conducts a tissue residue study to establish the withdrawal time for the generic product. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (61 FR 26182, May 24, 1996, Bioequivalence Guidance).
Based upon the formulation characteristics of the generic product, Fermenta Animal Health. was granted a waiver from conducting an in vivo bioequivalence study for sulfadimethoxine 12.5% oral solution. The generic and pioneer products are solutions which contain the same active and inactive ingredients
III. HUMAN FOOD SAFETY
The tolerances established for the pioneer drug product apply to the generic drug product. A tolerance of 0.1 ppm is established for the uncooked edible tissues of chickens, turkeys and cattle as per 21 CFR 556.640
When a waiver of in vivo bioequivalence testing is granted, the withdrawal times are those previously assigned to the pioneer product. The withdrawal times for sulfadimethoxine oral solution are 5 days for chickens and turkeys and 7 days for cattle.
Regulatory Method for Residues
The analytical method for detection of residue in tissue is the thin layer densitometric procedure. This method is found in the Official Methods of Analysis of the Association of Official Analytical Chemists, 15th edition, 1990.
IV. 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 sulfadimethoxine 12.5% oral solution when used under the proposed conditions of use, is safe and effective for its labeled indications.
- generic product labeling
- pioneer product labeling
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