Approval Date: September 15, 1993
Freedom of Information Summary
NADA 065-140
I. GENERAL INFORMATION:
NADA 065-140 Sponsor: Wade Jones Company
Lowell, Arkansas 72745Generic Name: tetracycline soluble powder Trade Name: TET-SOL 324 Marketing Status: Over the Counter (OTC) Effect of Supplement: The effectiveness tetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary. II. INDICATIONS FOR USE
CALVES AND SWINE: Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae, Klebsiella spp. susceptible to tetracycline hydrochloride.III. DOSAGE:
CHICKENS: Control of chronic respiratory disease (CRD, air sac disease) caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae susceptible to tetracycline hydrochloride.
TURKEYS: Control of infectious synovitis caused by Mycoplasma synoviae; bluecomb (transmissible enteritis, coronaviral enteritis) complicated by bacterial organisms susceptible to tetracycline hydrochloride.
IV. EFFECTIVENESS:
A. DOSAGE FORM Soluble Powder B. ROUTE OF ADMINISTRATION Oral (In drinking water) C. RECOMMENDED DOSAGES: 10 mg/pound body weight (calves & swine)
35 mg/pound body weight (turkeys)
200-800 mg/gal (chickens & turkeys)
V. ANIMAL SAFETY:NADA 065-140 was originally approved as safe for use as labeled on July 5, 1966. The drug was the subject of National Academy of Sciences/National Research Council (NAS/NRC) reports which were published in the FEDERAL REGISTER of July 8, 1970 (35 FR 10966). The Academy evaluated this drug as probably effective for oral treatment of animal diseases when such diseases are caused by pathogenic microorganisms sensitive to tetracycline hydrochloride, diseases such as: (1)Enteric and respiratory diseases in poultry (2) gastrointestinal and respiratory diseases in swine; (3) infected wounds, gastrointestinal and respiratory diseases in calves, sheep, and goats; (4) digestive system and respiratory diseases, pyelonephritis, peritonitis, infected wounds, abscesses, ulcers, and secondary bacterial invaders in dogs and cats; (5) coccidiosis in dogs; and (6) hexamitiasis in turkeys.
The Academy concluded that: ( 1 ) Most of the dosage directions provide for a less than effective dose, and the recommended minimum oral dose for large animals is 10 milligrams per pound of body weight daily in divided doses and for small animals 25 milligrams per pound of body weight in divided doses; (2) claims for the treatment of viral diseases must be limited to microorganisms belonging to the psittacosis-lymphogranuloma group; (3) each disease claim should be properly qualified as "appropriate for use in (name of disease) caused by pathogens sensitive to (name of drug), "and if the disease cannot be so qualified the claim must be dropped; (4) claims made "for prevention of" or "to prevent" should be replaced with "as an aid in the control of" or "to aid in the control of"; (5) as applicable, the manufacturer's label should warn that treated animals must actually consume enough medicated water or medicated feed to provide a therapeutic dose under the conditions that prevail; as a precaution, the label should state the desired oral dose per unit of animal weight per day for each species as a guide to effective use of the preparation in drinking water or feed.
The Food and Drug Administration concurs with the Academy's findings, interpreting the phrase "...cannot be so qualified..." in paragraph (3) to mean "...is not supported by adequate data..." (See Fed. Reg. vol. 35, NO. 131-Wed., July 8, 1970). FDA proceeded to review all available data relating to the effectiveness of products subject to NADA 065-140 to determine which label claims were supported by the requisite proof of effectiveness. That review resulted in a letter to the sponsor dated July 1, 1992, in which the agency stated that it had concluded that such data supported effectiveness only for the control and treatment of certain bacterial diseases susceptible to tetracycline hydrochloride in calves, swine, chickens and turkeys.
Thereafter, the sponsor complied with the evaluation of NAS/NRC and FDA's conclusions in the following manner:
1. The appropriate oral dose of 10 mg per pound body weight daily in certain species has been incorporated in the labeling. The 25 mg per pound body weight is appropriate for chickens and turkeys.
2. Claims for viral diseases have been deleted from the labeling completely.
3. Each disease claim on the label has been properly qualified with the appropriate genus and species of bacteria susceptible to tetracycline hydrochloride. Disease claims which were not so qualified have been deleted.
4. Claims made for prevention have been revised to read "Control of..." where appropriate.
5. The manufacturer's label carries the warning statement that treated animals must have the medicated water adjusted to compensate for variation in age and the weight of the animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption.
VI. HUMAN FOOD SAFETY:NADA 065-140 was originally approved as safe on July 5, 1966. No further safety data are required.
The NAS/NRC evaluation of the drug is concerned only with the effectiveness and safety of the drug for the treated animal. FDA's approval of the supplemental application did not involve reevaluation or reaffirmation of the human food safety data in the parent application.VII. AGENCY CONCLUSIONS:
§ 556.720 Tetracycline
A tolerance of 0.25 part per million has already been established for negligible residues of tetracycline in uncooked edible tissues of calves, swine, sheep, chickens, and turkeys.
Withdrawal times: 5 days (calves), 4 days (swine, chickens and turkeys).
This supplemental NADA satisfies the requirements of section 512 of the Act and demonstrates that TET-SOL 324 Tetracycline Soluble Powder when used under its proposed conditions of use, is safe and effective for the labeled indications for use in calves, swine, chickens and turkeys.
The "probably effective" finding of the NAS/NRC regarding Tetracycline hydrochloride which was published in the FEDERAL REGISTER of July 8, 1970, was subsequently reviewed by FDA, resulting in the upgrade to "effective" status with respect to the claims noted in the previous paragraph. The firm submitted revised labeling to conform and, therefore, this supplemental NADA complies with the NAS/NRC evaluation and FDA's conclusions.
TET-SOL 324 for use in food-producing animals is currently on the market as an over-the-counter product. When the NADA was reviewed under NAS / NRC / DESI program, it was an over-the-counter product and this marketing status remains unchanged. Therefore, the Center for Veterinary Medicine has concluded that this product should retain over-the-counter marketing status.
Under the Center's supplemental approval policy (21 CFR 514.106(b)(2)), this is a Category II change. The approval of this change is not expected to have any adverse effect on the safety or effectiveness of this new animal drug and, therefore, did not require a reevaluation of the human food or target animal safety data in the parent application.
Under the Generic Animal Drug and Patent Term Restoration Act of 1988, this approval does not qualify for an exclusivity period under section 512(c)(2)(F)(iii) of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 360b (c)(2)(F)(iii)) because the supplemental application does not contain reports of new clinical or field investigations (other than bioequivalence or residue studies), and in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) essential to the approval and conducted or sponsored by the applicant.
VIII. LABELING (Attached)
XXXXXXXXXXXXXXXXXXXX
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 20857Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.