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Home » 2009 Issues » 74 FR (06/04/2009) » E9-13015. Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor; Diclofenac; Ivermectin Otic Suspension

  E9-13015. Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor; Diclofenac; Ivermectin Otic Suspension  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for diclofenac sodium cream and ivermectin otic suspension from IDEXX Pharmaceuticals, Inc., to Boehringer Ingelheim Vetmedica, Inc.

    DATES:

    This rule is effective June 4, 2009.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-186 for SURPASS (diclofenac sodium) topical cream and NADA 141-174 for ACAREXX (ivermectin) otic suspension to Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002. Accordingly, the regulations are amended in 21 CFR 524.590 and 524.1195 to reflect the change of sponsorship.

    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.

    Start List of Subjects

    List of Subjects in 21 CFR Part 524

    • 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 524 is amended as follows:

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    PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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    1. The authority citation for 21 CFR part 524 continues to read as follows:

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

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    [Amended]
    Start Amendment Part

    2. In paragraph (b) of § 524.590, remove “065274” and in its place add “000010”.

    End Amendment Part
    [Amended]
    Start Amendment Part

    3. In paragraph (b) of § 524.1195, remove “065274” and in its place add “000010”.

    End Amendment Part Start Signature

    Dated: May 27, 2009.

    Bernadette Dunham,

    Director, Center for Veterinary Medicine.

    End Signature End Supplemental Information

    [FR Doc. E9-13015 Filed 6-3-09; 8:45 am]

    BILLING CODE 4160-01-S

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Document Information

Comments Received:
0 Comments
Effective Date:
6/4/2009
Published:
06/04/2009
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
E9-13015
Dates:
This rule is effective June 4, 2009.
Pages:
26782-26782 (1 pages)
Docket Numbers:
Docket No. FDA-2009-N-0665
PDF File:
e9-13015.pdf
CFR: (2)
21 CFR 524.590
21 CFR 524.1195