[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Page 48650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23245]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 Fort Dodge Laboratories. 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: September 20, 1995.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1617.
SUPPLEMENTARY INFORMATION: Fort Dodge Laboratories, 800 Fifth St. NW.,
P.O. Box 518, Fort Dodge, IA 50501, filed ANADA 200-142, 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.
ANADA 200-142 for Fort Dodge's flunixin meglumine injection is
approved as a generic copy of Banamine (flunixin meglumine)
Injection in Schering-Plough's NADA 101-479. The ANADA is approved as
of August 18, 1995, 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 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 carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 522
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 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 and 000856 in Sec. 510.600(c) of this
chapter.
* * * * *
Dated: September 5, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-23245 Filed 9-19-95; 8:45 am]
BILLING CODE 4160-01-F
