Animal & Veterinary
NADA 065-441 Polyotic - supplemental approval (April 23, 1993)
I. GENERAL INFORMATION
Princeton, NJ 08543
|Generic Name:||tetracycline soluble powder concentrate|
|Marketing Status:||Over the Counter (OTC)|
|Effect of Supplement:||The effectiveness tetracycline soluble powder concentrate 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: Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumonia (Haemophilus spp.), and Klebsiella spp. susceptible to tetracycline hydrochloride.
SWINE: Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumonia (Haemophilus spp.), and Klebsiella spp. susceptible to tetracycline hydrochloride.
A. DOSAGE FORM: Soluble Powder Concentrate
B. ROUTE OF ADMINISTRATION: Oral
C. RECOMMENDED DOSAGES: 10 mg/pound body weight.
NADA 65-441 was originally approved as safe for use as labeled on May 17,1954. 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:
- Enteric and respiratory diseases in poultry
- Gastrointestinal and respiratory diseases in swine;
- Infected wounds, gastrointestinal and respiratory diseases in calves, sheep, and goats;
- Digestive system and respiratory diseases, pyelonephritis, peritonitis, infected wounds, abscesses, ulcers, and secondary bacterial invaders in dogs and cats;
- Coccidiosis in dogs; and
- Hexamitiasis in turkeys.
The Academy concluded that:
- 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;
- Claims for the treatment of viral diseases must be limited to microorganisms belonging to the psittacosis-lymphogranuloma group;
- 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;
- 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";
- 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 65-441 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 and swine.
Thereafter, the sponsor complied with the evaluation of NAS/NRC and FDA's conclusions in the following manner:
- The appropriate oral dose of 10 mg per pound body weight daily in each species has been incorporated in the labeling.
- Claims for viral diseases have been deleted from the labeling completely.
- 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.
- Claims made for prevention have been revised to read "Control of..." where appropriate.
- 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.
V. ANIMAL SAFETY
NADA 65-441 was originally approved as safe on May 17, 1954. No further safety data are required.
VI. HUMAN FOOD SAFETY
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.
CFR Paragraph 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: 7 days -swine, 4 days-calves
VII. AGENCY CONCLUSIONS
This supplemental NADA satisfies the requirements of section 512 of the Act and demonstrates that POLYOTIC Soluble Powder Concentrate when used under its proposed conditions of use, is safe and effective for the labeled indications. The approval provides for use of POLYOTIC Soluble Powder Concentrate for the control and treatment of bacterial enteritis and bacterial pneumonia in swine and calves.
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.
POLYOTIC Soluble Powder Concentrate for use in food-producing animals is currently on the market as an over-the-counter product. The extensive over- the-counter marketing history of the products indicate that the conditions of use described in the labeling are reasonably certain to be followed in practice. 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 bioequivalency or residue studies) essential to the approval and conducted or sponsored by the applicant.
VIII. LABELING (Attached)
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 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.