[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
