[Federal Register Volume 60, Number 199 (Monday, October 16, 1995)]
[Rules and Regulations]
[Pages 53508-53509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25503]
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[[Page 53509]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Phenylbutazone Injection
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 the use of a generic phenylbutazone injection in horses as
an anti-inflammatory agent.
EFFECTIVE DATE: October 16, 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: Phoenix Scientific, Inc., 3915 South 48th
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, is the sponsor
of ANADA 200-126 which provides for the use of generic Phenylbutazone
20% Injection (200 milligrams (mg) of phenylbutazone per milliliter
(mL) of solution) for the relief of inflammatory conditions associated
with the musculoskeletal system in horses.
Approval of ANADA 200-126 for Phoenix Scientific's Phenylbutazone
20% Injection is as a generic copy of Coopers Animal Health's
Butazolidin (200 mg of phenylbutazone per mL) which is
covered by NADA 011-575. The ANADA is approved as of September 1, 1995,
and the regulations are amended in 21 CFR 522.1720 to reflect the
approval. The basis for approval is discussed in the freedom of
information summary.
In addition, the regulation contains an outdated footnote and
superscript references citing the National Academy of Science/National
Research Council (NAS/NRC) status of these products. The Generic Animal
Drug and Patent Term Restoration Act of 1988 changed that status. The
NAS/NRC footnote references are removed at this time.
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 522.1720 is amended by removing the footnote in
paragraphs (c) and (d) and by revising paragraph (b)(2) to read as
follows:
Sec. 522.1720 Phenylbutazone injection.
* * * * *
(b) * * *
(2) Approval for use of the 200 milligrams per milliliter drug in
horses: See sponsor Nos. 000010, 000402, 000864, and 059130 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: October 2, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-25503 Filed 10-13-95; 8:45 am]
BILLING CODE 4160-01-F
