[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Rules and Regulations]
[Page 29012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Orbifloxacin Tablet

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Schering-Plough Animal Health. The NADA provides for 
use of orbifloxacin for dogs for management of diseases associated with 
bacteria susceptible to orbifloxacin.

EFFECTIVE DATE: May 29, 1997.

FOR FURTHER INFORMATION CONTACT: John D. Baker, Center for Veterinary 
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1612.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health, Schering-
Plough Corp., P.O. Box 529, Kenilworth, NJ 07033, has filed NADA 141-
081 for OrbaxTM (orbifloxacin) tablets for dogs for the 
management of diseases associated with bacteria susceptible to 
orbifloxacin. The drug is limited to use by or on the order of a 
licensed veterinarian. The NADA is approved as of April 22, 1997, and 
the regulations are amended by adding new Sec. 520.1616 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii) a summary of safety and effectiveness data 
and information submitted to support approval of this application may 
be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning April 22, 1997, because no 
active ingredient including any ester or salt of the active ingredient, 
has been approved in any other application.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 520

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).
    2. New Sec. 520.1616 is added to read as follows:

Sec. 520.1616  Orbifloxacin tablets.

    (a) Specifications. Each tablet contains 5.7, 22.7, or 68 
milligrams of orbifloxacin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 2.5 to 7.5 milligrams 
per kilogram body weight.
    (ii) Indications for use. For management of diseases associated 
with bacteria susceptible to orbifloxacin.
    (iii) Limitations. Administer orally 2.5 milligrams per kilogram of 
body weight once daily for 2 to 3 days beyond cessation of clinical 
signs for up to a maximum of 30 days. May be increased to 7.5 
milligrams per kilogram if needed. For treatment of skin and associated 
soft tissue infections, administer for 2 to 3 days beyond cessation of 
clinical signs to a maximum of 30 days. For treatment of urinary tract 
infections, use for at least 10 consecutive days. If no improvement is 
seen within 5 days, diagnosis should be reevaluated and a different 
course of therapy considered. Orbifloxacin is contraindicated in 
immature dogs during the rapid growth phase. Orbifloxacin and other 
quinolones have been shown to cause arthropathy in immature animals of 
most species. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) [Reserved]

    Dated: May 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-14107 Filed 5-28-97; 8:45 am]
BILLING CODE 4160-01-F