[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