Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of methimazole tablets in cats for treatment of hyperthyroidism.
This rule is effective June 11, 2009.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, 240-276-8337, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Dechra, Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom, filed NADA 141-292 that provides for veterinary prescription use of FELIMAZOLE (methimazole) Coated Tablets in cats for the treatment of hyperthyroidism. The NADA is approved as of May 27, 2009, and the regulations are amended in 21 CFR part 520 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 Start Printed Page 27707a.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 on the date of approval.
FDA has determined under 21 CFR 25.33 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. Add § 520.1372 to read as follows:End Amendment Part
(a) Specifications. Each tablet contains 2.5 or 5 milligrams (mg) methimazole.
(b) Sponsor. See No. 043264 in § 510.600 of this chapter.
(c) Conditions of use in cats—(1) Amount. The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 levels and clinical response.
(2) Indications for use. For the treatment of hyperthyroidism.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Start Signature
Dated: June 5, 2009.
Director, Center for Veterinary Medicine.
[FR Doc. E9-13685 Filed 6-10-09; 8:45 am]
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