[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Rules and Regulations]
[Page 22888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10910]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
Meglumine
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 an abbreviated new animal drug
application (ANADA) filed by Agri Laboratories, Ltd. The ANADA provides
for use of flunixin meglumine injection in horses for alleviation of
inflammation and pain associated with musculoskeletal disorders and
visceral pain associated with colic.
EFFECTIVE DATE: April 28, 1997.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1617.
SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St.
Joseph, MO 64503, filed ANADA 200-061, which provides for intravenous
or intramuscular use of flunixin meglumine injection in horses for
alleviation of inflammation and pain associated with musculoskeletal
disorders and visceral pain associated with colic. Flunixin meglumine
is for veterinary prescription use only.
Approval of ANADA 200-061 for Agri Laboratories' flunixin meglumine
injection is as a generic copy of Schering-Plough's Banamine
(flunixin meglumine) Solution (injection) NADA 101-479. The ANADA is
approved as of September 11, 1996, and the regulations are amended in
21 CFR 522.970(b) 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
The firm has submitted an abbreviated environmental assessment. In
response, FDA has prepared a finding of no significant impact. The
agency has determined under 21 CFR 25.24(d)(1)(i) 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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 522.970 is amended by revising paragraph (b) to read as
follows:
Sec. 522.970 Flunixin meglumine solution.
* * * * *
(b) Sponsors. See Nos. 000061, 000856, 057561, and 059130 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: April 8, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-10910 Filed 4-25-97; 8:45 am]
BILLING CODE 4160-01-F