[Federal Register Volume 60, Number 208 (Friday, October 27, 1995)]
[Rules and Regulations]
[Pages 54941-54942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26633]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable New Animal Drugs; Flunixin Meglumine
Solution
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 Phoenix Scientific, Inc. The ANADA
provides for intravenous or intramuscular use of flunixin meglumine
injection for alleviation of inflammation and pain associated with
musculoskeletal disorders and visceral pain associated with colic in
horses.
EFFECTIVE DATE: October 27, 1995.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1616.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
124, which provides for intravenous or intramuscular use of flunixin
meglumine injection for alleviation of inflammation and pain associated
with musculoskeletal disorders and visceral pain associated with colic
in horses.
Approval of ANADA 200-124 for Phoenix Scientific's flunixin
meglumine injection is as a generic copy of Banamine
(flunixin meglumine) Injection in Schering-Plough Animal Health's NADA
101-479. The ANADA is approved as of September 25, 1995, and the
regulations are amended in Sec. 522.970(b) (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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
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:
[[Page 54942]]
Sec. 522.970 Flunixin meglumine solution.
* * * * *
(b) Sponsors. See Nos. 000061, 000856, and 059130 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: October 17, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-26633 Filed 10-26-95; 8:45 am]
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