[Federal Register Volume 63, Number 186 (Friday, September 25, 1998)]
[Rules and Regulations]
[Page 51300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25639]
[[Page 51300]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Etodolac 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 new animal drug application
(NADA) filed by Fort Dodge Animal Health. The NADA provides for oral
veterinary prescription use of etodolac tablets for the management of
pain and inflammation associated with osteoarthritis in dogs.
EFFECTIVE DATE: September 25, 1998.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1618.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, A Division of
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501, filed NADA
141-108 that provides for oral veterinary prescription use of
EtogesicTM (etodolac) tablets for the management of pain and
inflammation associated with osteoarthritis in dogs. The NADA is
approved as of July 22, 1998, and the regulations are amended by adding
21 CFR 520.870 to reflect the approval. The basis for 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
Under 21 U.S.C. 360b(c)(2)(F)(i), this approval qualifies for 5
years of marketing exclusivity beginning July 22, 1998, because no
active ingredient of the drug, including any ester or salt of the
active ingredient, has been previously approved in any other
application filed under section 512(b)(1) of the act.
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
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.
2. Section 520.870 is added to read as follows:
Sec. 520.870 Etodolac.
(a) Specifications. Each tablet contains 150 or 300 milligrams
(mg) of etodolac.
(b) Sponsor. See 053501 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Dogs--(i) Amount. 10 to 15 mg per
kilogram (4.5 to 6.8 mg/pound) of body weight per day.
(ii) Indications for use. For the management of pain and
inflammation associated with osteoarthritis in dogs.
(iii) Limitations. Use once-a-day. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(2) [Reserved]
Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25639 Filed 9-24-98; 8:45 am]
BILLING CODE 4160-01-F
