Approval Date: December 2, 1997
I. GENERAL INFORMATION
Hoffmann-La Roche Inc.
340 Kingsland Street
Nutley, New Jersey 07110
chlortetracycline, sulfathiazole, and penicillin
Over the Counter (OTC)
- Generic Name: Chlortetracycline, sulfathiazole and penicillin
- Trade Name: AUREOZOL®
- Dosage Form: Type A Medicated Article
- How Supplied: 50 lb. (22.7 kg) bag
- How Dispensed: Over -the-counter (OTC)
- Label Claim of Amount of Active Ingredient(s):
- Chlortetracycline calcium complex equivalent to chlortetracycline HCl: 20 g/lb. of Type A Medicated Article
- Sulfathiazole: 4.4% (20 g/lb) of Type A Medicated Article
- Penicillin (from procaine penicillin): 10 g/lb of Type A Medicated Article
- Route of Administration: Orally in complete feed.
- Labeled Dosage: Mix 5 pounds of AUREOZOL® into each ton (907.2 kg) of complete swine feed (providing 100 grams of chlortetracycline, 100 grams of sulfathiazole and 50 grams of penicillin per ton of feed).
- Species: Swine
- Indications for Use:
- Pre-Starter and Starter Feeds: Administer to swine in a complete feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain and improved feed efficiency from 10 pounds of body weight to 6 weeks post-weaning. For swine raised in confinement (dry lot) or on limited pasture.
- Grower and Finisher Feeds: Administer to swine in a complete feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (Salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain from 6 to 16 weeks post-weaning. For swine raised in confinement (dry lot) or on limited pasture.
- Pioneer Product:
- CSP 250 Fermazole Brand
Chlortetracycline (as hydrochloride), Sulfathiazole,
Penicillin (from Procaine Penicillin)
Fermenta Animal Health Company
- CSP 250 Fermazole Brand
II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS
In accordance with the provisions of the Federal Food, Drug and Cosmetic Act, as amended by the Generic Animal Drug and Patent Restoration Act and the Center's first policy letter (53 FR 50460, December 15, 1988) and the Center's fifth policy letter (June 18, 1990, 55 FR 24645), Hoffmann-La Roche, Inc. is entitled to the approval of the generic chlortetracycline, sulfathiazole and penicillin combination. In vivo bioequivalence studies were not required for the approval of this generic chlortetracycline, sulfathiazole, and penicillin combination because both active and inactive ingredients, and all the entire manufacturing processes are identical to methods of the pioneer. The active ingredients are also produced using the same manufacturing processes as the pioneer active ingredients. The manufacturing site for the production of the generic combination is an approved alternate manufacturing site for the pioneer product. The combination of chlortetracycline, sulfathiazole, and penicillin is codified under 21 CFR § 558.155.
III. HUMAN FOOD SAFETY
The tolerance established for the pioneer product applies to the generic product. A tolerance of 0.1 ppm is established for negligible residues of sulfathiazole in the edible tissues of swine (21 CFR § 556.690). At 7-days withdrawal, residues of chlortetracycline and penicillin in edible tissues are also negligible. The established tolerance for residues of penicillin is zero in the edible tissues of swine (21 CFR § 556.510). The established tolerances for the sum of residues of tetracyclines (chlortetracycline, oxytetracycline, tetracycline) are 12 ppm in swine fat and kidney, 6 ppm in swine liver, and 2 ppm in swine muscle [21 CFR § 556.150].
When a waiver of in vivo bioequivalence testing is granted, the generic product will be assigned the same withdrawal period as the pioneer product. The withdrawal period for the Type A medicated article containing chlortetracycline, sulfathiazole, and penicillin is established under 21 CFR § 558.155 and is 7 days. The withdrawal period is based on depletion of sulfathiazole from the edible tissues of swine. At 7 days withdrawal, residues of penicillin and chlortetracycline will also be below their respective tolerances.
Regulatory Method for Residues
The regulatory analytical methods for detection of residues of penicillin and chlortetracycline are microbiological assay procedures (Antibiotic Residues in Milk, Dairy Products and Animal Tissues: Methods, Reports and Protocols, FDA, 1968). The regulatory method of detection for sulfathiazole residues is colorimetric. It is described in the USDA FSIS Analytical Chemistry Laboratory Guidebook-Residue Chemistry; Winter 1991, pp. 1-23 (Determinative method). The methods are on file at the Center for Veterinary Medicine, Food and Drug Administration, HFV-199, 7500 Standish Place, Rockville, Maryland 20855.
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 chlortetracycline, sulfathiazole, penicillin (AUREOZOL®) Type A Medicated Article when used under its proposed conditions of use, is safe and effective for the labeled indications.
V. APPROVED GENERIC AND PIONEER LABELING
A copy of the draft facsimile generic and approved pioneer labeling is attached to this document.
- AUREOZOL® Type A Medicated Article Generic Labeling
- CSP 250 Fermazole Brand Type A Medicated Article Pioneer Label
- AUREOZOL® Type B Medicated Feed Bluebird Label
- AUREOZOL® Type C Medicated Feed Bluebird 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