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Implantation or Injectable Dosage Form New Animal Drugs; Phenylbutazone Injection

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 [Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Rules and Regulations]
[Page 48272-48273]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au05-4]

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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 an abbreviated new animal drug 
application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA 
provides for the veterinary prescription use of phenylbutazone 
injectable solution in horses for relief of inflammatory conditions 
associated with the musculoskeletal system.

DATES: This rule is effective August 17, 2005.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV 104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
john.harshman@fda.gov.

SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe 
Trail Dr., Lenexa , KS 66215-3591, filed ANADA 200-371 for the use of 
Phenylbutazone 20% Injection by veterinary prescription for relief of 
inflammatory conditions associated with the musculoskeletal system in 
horses. Sparhawk Laboratories, Inc.'s, Phenylbutazone 20% Injection is 
approved as a generic copy of Schering-Plough Animal Health Corp.'s, 
BUTAZOLIDIN Injectable 20%, approved under NADA 11-575. The ANADA is 
approved as of July 8, 2005, and the regulations in 21 CFR 522.1720 are 
amended to reflect the approval. The basis of approval is discussed in 
the freedom of information(FOI) summary.
    In accordance with the FOI provisions of 21 CFR part 20 and 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 Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore,

[[Page 48273]]

neither an environmental assessment nor an environmental impact 
statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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: 21 U.S.C. 360b.

Sec.  522.1720  [Amended]

? 2. Section 522.1720 is amended in paragraph (b)(2) by removing ``No. 
000010'' and by adding in its place ``Nos. 000010 and 058005''.

    Dated: July 26, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-16240 Filed 8-16-05; 8:45 am]
BILLING CODE 4160-01-S

 
 

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