Approval Date: February 23, 1994
I. GENERAL INFORMATION:
Hoechst-Roussel Agri-Vet Company
P.O. Box 2500
Somerville, New Jersey 08876-1258
Over the Counter (OTC)
- Established Name: Salinomycin sodium
- Trade/Proprietary Name: Sacox®
- Dosage Form: Type A medicated article
- How Supplied: Salinomycin is supplied in 50 lb bags
- How Dispensed: OTC
- Amount of Active Ingredient: Salinomycin equivalent to 30 grams salinomycin sodium per pound
- Route of Administration: Administer orally by adding the Type A medicated article to complete broiler feed (Type C medicated feed).
- Labeled Dosage: Sacox® can be used to provide concentrations of salinomycin ranging from 40 to 60 g/ton.
- Species: Broiler Chickens
- Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati
- Pioneer Product/"Listed" Product: Bio-Cox; salinomycin sodium; NADA # 128-686; Agri-Bio Corporation
- Date of Approval: February 23, 1994
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. 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).
Where as waivers for Type A medicated articles are not addressed in the Bioequivalence Guideline, Hoechst-Roussel Agri-Vet Company was granted a waiver from conducting an in vivo bioequivalence study for salinomycin sodium as a Type A medicated article. The bioequivalence of the pioneer and generic products was considered to be self-evident, because the products are Type A medicated articles with the active ingredient from the same source (manufacturer), and the products contain the same inactive ingredients.
III. HUMAN FOOD SAFETY:
- Safe Concentration of Residues
The safe concentrations for total salinomycin residues in the uncooked edible tissues of broiler chickens were established as 0.6 ppm in muscle, 1.8 ppm in liver, and 1.2 ppm in skin/fat (48 FR 30616, July 5, 1983). An upper limit of unchanged salinomycin in skin/fat is established at 200 ppb.
- Withdrawal Time
When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal period assigned to the generic product is the same as that previously assigned to the pioneer product. A zero withdrawal is established for salinomycin sodium in broiler feed.
- Regulatory Method:
A regulatory method was not required because the generic product is assigned a zero withdrawal.
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 salinomycin sodium when used under the proposed conditions of use, is safe and effective for its labeled indications.
The following generic labeling and currently approved pioneer labeling are available.
- Package label for generic Type A medicated article - Sacox
- Package bluebird label for generic Type C medicated feed
- Pioneer package label for Type A medicated article - Biocox
Copies 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