[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)]
[Rules and Regulations]
[Page 148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Prednisolone Tablets
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 supplemental new animal drug
application (NADA) filed by Lloyd, Inc. The supplemental NADA provides
for an additional strength prednisolone tablet for dogs for use as an
anti-inflammatory agent.
EFFECTIVE DATE: January 5, 1998.
FOR FURTHER INFORMATION CONTACT: Dennis M. Bensley, Center for
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1705.
SUPPLEMENTARY INFORMATION: Lloyd, Inc., 604 West Thomas Ave.,
Shenandoah, IA 51601, is the sponsor of NADA 140-921 that provides for
use of prednisolone tablets for dogs as an anti-inflammatory agent.
Lloyd, Inc., filed a supplemental NADA that provides for use of a 20
milligram (mg) prednisolone tablet in addition to the currently
approved 5 mg tablet. The supplemental NADA is approved as of November
20, 1997, and the regulations are amended in Sec. 520.1880(a) (21 CFR
520.1880(a)) to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
In addition, the drug's name in Sec. 520.1880(a) is amended to read
``prednisolone.''
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.
The agency has determined under 21 CFR 25.33(d)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects in 21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the 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: 21 U.S.C. 360b.
Sec. 520.1880 [Amended]
2. Section 520.1880 Prednisolone tablets is amended in paragraph
(a) by removing ``5 milligrams prednisolene'' and adding in its place
``5 or 20 milligrams prednisolone.''
Dated: December 17, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 98-74 Filed 1-2-98; 8:45 am]
BILLING CODE 4160-01-F