-
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 approval of a supplemental abbreviated new animal drug application (ANADA) filed by IMPAX Laboratories, Inc. The supplemental ANADA provides for veterinary prescription use of carprofen caplets in dogs for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
DATES:
This rule is effective September 1, 2006.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: john.harshman@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544, filed a supplement to ANADA 200-366 for NOVOX (carprofen) caplets which are approved for veterinary prescription use in dogs for the relief of pain and inflammation associated with osteoarthritis (70 FR 30625, May 27, 2005). The supplement provides for use of NOVOX caplets for the control of postoperative pain associated with soft tissue and orthopedic surgeries. The supplemental ANADA is approved as of July 27, 2006, and 21 CFR 520.309 is amended to reflect the approval.
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.
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.
Start List of SubjectsList of Subjects 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:
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment Part Start Amendment Part2. In § 520.309, remove paragraphs (d)(2)(i) and (d)(2)(ii), and revise paragraphs (b)(2) and (d)(2) to read as follows:
End Amendment PartCarprofen.(b) * * *
(2) No. 000115 for use of product described in paragraph (a)(1) as in paragraph (d) of this section.
(d) * * *
(2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
* * * * *Start SignatureDated: August 18, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E6-14508 Filed 8-31-06; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Effective Date:
- 9/1/2006
- Published:
- 09/01/2006
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- E6-14508
- Dates:
- This rule is effective September 1, 2006.
- Pages:
- 51995-51995 (1 pages)
- PDF File:
- e6-14508.pdf
- CFR: (1)
- 21 CFR 520.309