[Federal Register: December 5, 2007 (Volume 72, Number 233)]
[Rules and Regulations]
[Page 68477-68478]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de07-3]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Oral Dosage Form New Animal Drugs; Carprofen
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
[[Page 68478]]
animal 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.
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.
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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
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 parts 510 and
520 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
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:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * *
Belcher Pharmaceuticals, Inc., 12393 062250
Belcher Rd., suite 420, Largo, FL 33773
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
062250 Belcher 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 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.309 [Amended]
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4. In paragraph (b)(2) of Sec. 520.309, remove ``No. 000115'' and add
in its place ``Nos. 000115 and 062250''.
Dated: November 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-23516 Filed 12-4-07; 8:45 am]
BILLING CODE 4160-01-S