[Federal Register Volume 69, Number 239 (Tuesday, December 14, 2004)]
[Rules and Regulations]
[Pages 74418-74419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Furosemide

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 veterinary prescription use of furosemide syrup in dogs by 
oral administration for treatment of edema associated with cardiac 
insufficiency and acute noninflammatory tissue edema.

DATES: This rule is effective December 14, 2004.

[[Page 74419]]


FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Ter., St. Joseph, MO 64503, filed ANADA 200-382 for veterinary 
prescription use of Furosemide Syrup 1% in dogs by oral administration 
for treatment of edema associated with cardiac insufficiency and acute 
noninflammatory tissue edema. Phoenix Scientific's Furosemide Syrup 1% 
is approved as a generic copy of Intervet, Inc.'s LASIX (furosemide) 
Syrup 1%, approved under NADA 102-380. The ANADA is approved as of 
November 18, 2004, and the regulations are amended in 21 CFR 520.1010 
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 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.
    FDA 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, 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 520

    Animal drugs.

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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 520 is 
amended as follows:

PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. Section 520.1010 is amended by adding paragraph (b)(4) to read as 
follows:


Sec.  520.1010  Furosemide.

* * * * *
    (b) * * *
    (4) No. 059130 for use of syrup in paragraph (a)(4) of this section 
for conditions of use in paragraph (d)(2)(i) and (d)(2)(ii)(A) of this 
section.
* * * * *

    Dated: December 6, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-27291 Filed 12-13-04; 8:45 am]
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