Oral Dosage Form New Animal Drugs: Methimazole

Federal Register: June 11, 2009 (Volume 74, Number 111)

Rules and Regulations

Page 27706-27707

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr11jn09-12

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 520

Docket No. FDA-2009-N-0665

Oral Dosage Form New Animal Drugs; Methimazole

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: 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.

DATES: This rule is effective June 11, 2009.

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: 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

Page 27707

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 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.

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. Add Sec. 520.1372 to read as follows:

Sec. 520.1372 Methimazole.

(a) Specifications. Each tablet contains 2.5 or 5 milligrams (mg) methimazole.

(b) Sponsor. See No. 043264 in Sec. 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.

Dated: June 5, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

FR Doc. E9-13685 Filed 6-10-09; 8:45 am

BILLING CODE 4160-01-S