Document ID: FDA-2009-N-0665-0024
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Luprostiol
Posted Date: 2009-05-27T04:00Z

[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Rules and Regulations]               
[Page 25146-25147]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my09-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
Implantation or Injectable Dosage Form New Animal Drugs; Change 
of Sponsor; Luprostiol

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 a change of sponsor for luprostiol 
injectable solution from Intervet, Inc., to Virbac AH, Inc.

DATES: This rule is effective May 27, 2009.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 140-857 for 
EQUESTROLIN (luprostiol) injectable solution to Virbac AH, Inc., 3200 
Meacham Blvd., Ft. Worth, TX 76137. Accordingly, the regulations are 
amended in 21 CFR 522.1290 to reflect the change of sponsorship and a 
current format.
    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.

0
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

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. In Sec.  522.1290, revise the section heading and paragraphs (a), 
(b), and (d) to read as follows:

[[Page 25147]]

Sec.  522.1290  Luprostiol.

    (a) Specifications. Each milliliter of solution contains 7.5 
milligrams (mg) luprostiol.
    (b) Sponsor. See No. 051311 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in horses--(1) Amount. 7.5 mg by 
intramuscular injection.
    (2) Indications for use. For estrus control and termination of 
pregnancy in mares.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Do not use in horses intended for 
human consumption.

    Dated: May 12, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-12269 Filed 5-26-09; 8:45 am]

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