[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.
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    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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