Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Merial Ltd. The NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of pain and inflammation associated with osteoarthritis.
This rule is effective August 18, 2004.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed NADA 141-230 for PREVICOX (firocoxib) Tablets. The application provides for the veterinary prescription use of firocoxib chewable tablets in dogs for the control of pain and inflammation associated with osteoarthritis. The NADA is approved as of July 21, 2004, and 21 CFR part 520 is amended by adding new § 520.928 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
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)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning July 21, 2004.
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.Start List of Subjects
List of Subjects in 21 CFR Part 520End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. Section 520.928 is added to read as follows:End Amendment Part
(a) Specifications. Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib.
(b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. 5 mg per kilogram (2.27 mg per pound) body weight once daily.Start Printed Page 51172
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Start Signature
Dated: August 2, 2004.
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-18897 Filed 8-17-04; 8:45 am]
BILLING CODE 4160-01-S