Justia Regulation Tracker

---

[Federal Register: October 31, 2008 (Volume 73, Number 212)]
[Rules and Regulations]               
[Page 64885]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc08-10]                         

[[Page 64885]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

 
Oral Dosage Form New Animal Drugs; Firocoxib Tablets

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 new animal drug 
application (NADA) filed by Merial Ltd. The supplemental NADA provides 
for veterinary prescription use of firocoxib chewable tablets in dogs 
for the control of postoperative pain and inflammation associated with 
orthopedic surgery.

DATES: This rule is effective October 31, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-230 for 
PREVICOX (firocoxib) Chewable Tablets. The supplemental application 
provides for the veterinary prescription use of firocoxib chewable 
tablets in dogs for the control of postoperative pain and inflammation 
associated with orthopedic surgery. The NADA is approved as of 
September 23, 2008, and the regulations in 21 CFR 520.928 are 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    The agency has determined under 21 CFR 25.33(d)(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 in 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 part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. In Sec.  520.928, revise paragraphs (c)(1) and (c)(2) to read as 
follows:

Sec.  520.928  Firocoxib tablets.

* * * * *
    (c) * * *
    (1) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily 
for osteoarthritis. Administer approximately 2 hours before soft-tissue 
or orthopedic surgery.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis; and for the control of postoperative 
pain and inflammation associated with soft-tissue and orthopedic 
surgery.
* * * * *

    Dated: October 17, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-26020 Filed 10-30-08; 8:45 am]

BILLING CODE 4160-01-P