71 FR 23 pg. 5788 - Oral Dosage Form New Animal Drugs; Firocoxib Paste
Type: RULEVolume: 71Number: 23Page: 5788
FR document: [FR Doc. 06-993 Filed 2-2-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Firocoxib Paste
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration(FDA) is amending the animal drug regulations to reflect approvalof a new animal drug application (NADA) filed by Merial Ltd. TheNADA provides for veterinary prescription use of firocoxib oralpaste in horses for the control of pain and inflammationassociated with osteoarthritis.
DATES:
This rule is effective February 3, 2006.
FOR FURTHER INFORMATION CONTACT:
Melanie R.Berson, Center for Veterinary Medicine (HFV-110), Food andDrug Administration, 7500 Standish Pl., Rockville, MD 20855,301-827-7540, e-mail: melanie.berson@fda.gov .
SUPPLEMENTARY INFORMATION:
Merial Ltd.,3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640,filed NADA 141-253 for veterinary prescription use ofEQUIOXX (firocoxib) oral paste for the control of pain andinflammation associated with osteoarthritis in horses. The NADAis approved as of December 30, 2005, and 21 CFR part 520 isamended by adding new § 520.930 to reflect theapproval. The basis of approval is discussed in the freedom ofinformation summary.
In accordance with the freedom of information provisions of 21CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety andeffectiveness data and information submitted to support approvalof this application may be seen in the Division of DocketsManagement (HFA-305), Food and Drug Administration, 5630Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4p.m., Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, andCosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approvalqualifies for 3 years of marketing exclusivity beginning December30, 2005.
The agency has determined under 21 CFR 25.33(d)(1) that thisaction is of a type that does not individually or cumulativelyhave a significant effect on the human environment. Therefore,neither an environmental assessment nor an environmental impactstatement 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 "particularapplicability." Therefore, it is not subject to thecongressional review requirements in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Actand under authority delegated to the Commissioner of Food andDrugs and redelegated to the Center for Veterinary Medicine, 21CFR part 520 is amended as follows:
PART 520-ORAL DOSAGE FORM NEW ANIMALDRUGS
1. The authority citation for 21 CFR part 520 continuesto read as follows:
Authority:
21 U.S.C.360b.
2. Revise the section heading of § 520.928 toread as follows:
§ 520.928 Firocoxibtablets.
3. Add § 520.930 to read as follows:
§ 520.930 Firocoxibpaste.
(a) Specifications . Each milligram (mg) ofpaste contains 0.82 mg firocoxib.
(b) Sponsors . See No. 050604 in§ 510.600(c) of this chapter.
(c) Conditions of use in horses -(1) Amount . 0.1 mg per kilogram (0.045 mg per pound) bodyweight daily for up to 14 days.
(2) Indications for use . For the control ofpain and inflammation associated with osteoarthritis.
(3) Limitations . Do not use in horses intendedfor human consumption. Federal law restricts this drug to use byor on the order of a licensed veterinarian.
Dated: January 18, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-993 Filed 2-2-06; 8:45 am]
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