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Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution

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 [Federal Register: January 13, 2005 (Volume 70, Number 9)]
[Rules and Regulations]
[Page 2352-2353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja05-17]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
 
Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution

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 use of levamisole hydrochloride soluble powder to make a 
drench solution for oral administration to cattle and sheep which is 
effective against various internal parasites.

DATES: This rule is effective January 13, 2005.

[[Page 2353]]

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: 
lonnie.luther@fda.gov.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed ANADA 200-386 for Levamisole 
Hydrochloride Soluble Drench Powder used to make a drench solution for 
oral administration to cattle and sheep which is effective against 
various internal parasites. Phoenix Scientific's Levamisole 
Hydrochloride Soluble Drench Powder is approved as a generic copy of 
Schering-Plough Animal Health Corp.'s, LEVASOL (levamisole 
hydrochloride) Soluble Drench Powder, approved under NADA 112-051. The 
ANADA is approved as of December 17, 2004, and the regulations are 
amended in 21 CFR 520.1242a 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 Subject in 21 CFR Part 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

    Authority: 21 U.S.C. 360b.
? 2. Section 520.1242a is amended by revising paragraphs (a) and (b)(4) 
to read as follows:

Sec.  520.1242a  Levamisole powder for oral solution.

    (a) Specifications. Each package of powder contains 9.075, 11.7, 
18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.
    (b) * * *
    (4) No. 059130 for use of 46.8-, 362.7-, and 544.5-g packages as in 
paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), 
(e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 
18.15-g package as in paragraph (e)(3) of this section.
* * * * *

    Dated: January 6, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-675 Filed 1-12-05; 8:45 am]
BILLING CODE 4160-01-S

 
 

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