NADA 140-441 and 140-913

Links to original documents are no longer valid. The Freedom of Information Act allows use of these FDA documents, now hosted here. File has been slightly reformatted.

FOI Summary; NADA 140-441 and 140-913 (supplemental); Baytril® Antibacterial Tablets and Baytril® Antibacterial Injectable Solution (enrofloxacin); re: dosage frequency, indications, and limitations; June 19, 1997
--Editor's abstract

Freedom of Information Summary
NADA 140-441 and 140-913

I. GENERAL INFORMATION:

NADA Numbers: 140-441 and 140-913

Sponsor:

BAYER Corporation
Agriculture Division
Animal Health
P.O. Box 390
Shawnee, Kansas 66201

Established name: enrofloxacin tablets and enrofloxacin injectable solution

Trade name: BAYTRIL® Antibacterial Tablets and BAYTRIL® Antibacterial Injectable Solution

Marketing status: prescription

Effect of the Supplement:

The supplement to NADA 140-441, for dogs and cats, provides for revisions to 21 CFR 520.812 as indicated below.

Conditions of use - (1) Amount. Administer orally at a rate to provide 5 to 20 mg/kg (2.27 to 9.07 mg/lb) of body weight, either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

(2) Indications - Enrofloxacin tablets in dogs and cats for the management of diseases associated with bacteria susceptible to enrofloxacin. [This statement will replace section (2)(i) and (ii) as previously approved].

(3) Limitations - Treatment should be continued for at least 2 to 3 days beyond cessation of clinical signs, to a maximum of 30 days for both dogs and cats.

The supplement to NADA 140-913, for dogs, provides for revisions to 21 CFR 522.812 as indicated below.

(2) Indications - Enrofloxacin injectable solution in dogs for the management of diseases associated with bacteria susceptible to enrofloxacin.

II. INDICATIONS FOR USE

Baytril Antibacterial Tablets and Injectable Solution are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to enrofloxacin.

III. PRODUCT INFORMATION

A. Dosage form: 5.7 mg, 22.7 mg, and 68 mg enrofloxacin per tablet, and 22.7 mg per mL

B. Route of administration: Baytril Antibacterial Tablets for oral administration and Baytril Injectable Solution for intramuscular administration

C. Recommended dosage: The dose range of Baytril Antibacterial Tablets in dogs and cats is 5 to 20 mg/kg (2.27 to 9.07 mg/lb) of body weight, either as a single dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose of Baytril Injectable Solution for dogs is 2.5 mg/kg (1.13 mg/lb) as a single injection. The injectable dose should be followed by oral tablet treatment in 12 hours.

IV. EFFECTIVENESS

A. Clinical efficacy of the recommended minimum dosages have been established in dogs as indicated and referenced in the Freedom of Information Summaries for NADA 140-441 dated January 24, 1989, May 4, 1990, and October 29, 1990, and NADA 140-913 dated January 29, 1990.

B. The drugs distribute widely and reach adequate blood and tissue concentrations in the target animal species. Tissue concentration values are found in the approved labels, and are presented, or referenced, in the Freedom of Information Summaries associated with these approvals.

The wide distribution and activity of these drugs would indicate that the drugs may be used in several conditions, and is evidenced by the wide range of recommended conditions, indications, and limitations in clinical literature as indicated in Table 1.