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Rule

Oral Dosage Form New Animal Drugs; Carprofen

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the Start Printed Page 68478animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Belcher Pharmaceuticals, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs.

DATES:

This rule is effective December 5, 2007.

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FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: john.harshman@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., Suite 420, Largo, FL 33773, filed ANADA 200-397 for VETPROFEN (carprofen) Caplets. The ANADA provides for veterinary prescription use in dogs for the relief of pain and inflammation associated with osteoarthritis, and for the control of postoperative pain associated with soft tissue and orthopedic surgeries. Belcher Pharmaceuticals, Inc.'s VETPROFEN Caplets are approved as a generic copy of RIMADYL Caplets, sponsored by Pfizer, Inc., under NADA 141-053. The ANADA is approved as of November 7, 2007, and 21 CFR 520.309 is amended to reflect the approval.

In addition, Belcher Pharmaceuticals, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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, 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.

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List of Subjects

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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,

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding a new entry for “Belcher Pharmaceuticals, Inc.” and in the table in paragraph (c)(2) by numerically adding a new entry for “062250” to read as follows:

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Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773062250
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
062250Belcher Pharmaceuticals, Inc., 12393 Belcher Rd., suite 420, Largo, FL 33773
*    *    *    *    *
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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for

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

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[Amended]
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4. In paragraph (b)(2) of § 520.309, remove “No. 000115” and add in its place “Nos. 000115 and 062250”.

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Dated: November 20, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. E7-23516 Filed 12-4-07; 8:45 am]

BILLING CODE 4160-01-S