[Federal Register Volume 61, Number 203 (Friday, October 18, 1996)]
[Rules and Regulations]
[Pages 54332-54333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26685]
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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;
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 a supplemental abbreviated new
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The
supplemental ANADA provides for use of phenylbutazone injection in dogs
for relief of inflammatory conditions associated with the
musculoskeletal system.
EFFECTIVE DATE: October 18, 1996.
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
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed a
supplement to ANADA 200-126 which provides for intravenous use of
phenylbutazone injection in dogs for relief of inflammatory conditions
associated with the musculoskeletal system. The ANADA is currently
approved for use of the drug in horses. The drug is limited to use by
or on the order of a licensed veterinarian.
Approval of supplemental ANADA 200-126 for Phoenix's phenylbutazone
injection 20 percent is as a generic copy of Cooper's NADA 11-575
Butazolidin Injectable 20 percent (phenylbutazone).
Supplemental ANADA 200-126 is approved as of September 6, 1996, and the
regulations are amended by revising Sec. 522.1720(b) (21 CFR
522.1720(b)), to reflect the approval. The basis of 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, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between
[[Page 54333]]
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 revising paragraphs (b)(1) and
(b)(2) to read as follows:
Sec. 522.1720 Phenylbutazone injection.
* * * * *
(b) Sponsors. (1) Approval for use of the 200 milligrams per
milliliter drug in dogs and horses: See sponsor Nos. 000031, 011716,
015579, and 059130 in Sec. 510.600(c) of this chapter.
(2) Approval for use of the 200 milligrams per milliliter drug for
use in horses: See sponsor Nos. 000010, 000402, and 000864 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: October 4, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-26685 Filed 10-17-96; 8:45 am]
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