E6-10406. Oral Dosage Form New Animal Drugs; Griseofulvin

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 new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of griseofulvin powder orally as a systemic antifungal agent in horses.

DATES:

This rule is effective July 5, 2006.

FOR FURTHER INFORMATION CONTACT:

Daniel A. Benz, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0223, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200-391 that provides for veterinary prescription use of Griseofulvin Powder Microsize, orally as a systemic antifungal agent in horses. IVX Animal Health's Griseofulvin Powder Microsize, is approved as a generic copy of Schering-Plough Animal Health Corp.'s FULVICIN-U/F (griseofulvin) Powder approved under NADA 39-792. The ANADA is approved as of June 1, 2006, and the regulations are amended in 21 CFR 520.1100 to reflect the approval and a current format. 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.

The agency has determined under 21 CFR 25.33(a)(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

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

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

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

2. Amend § 520.1100 as follows:

a. Revise paragraphs (a), (b), (c), and (d)(1);

b. Remove paragraphs (d)(2) and (d)(3)(iii); and

c. Redesignate paragraphs (d)(3) introductory text, (d)(3)(i), (d)(3)(i)( a), (d)(3)(i)(b), and (d)(3)(ii) as paragraphs (d)(2) introductory text, (d)(2)(i), (d)(2)(i)(A), (d)(2)(i)(B), and (d)(2)(ii).

The revisions read as follows:

§ 520.1100

Griseofulvin.

(a) Specifications—(1) The powder complies with U.S.P. for griseofulvin, microsize.

(2) Each bolus contains 2.5 grams griseofulvin.

(3) Each tablet contains 125 or 500 milligrams griseofulvin.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) No. 000061 for use of products described in paragraph (a) for use as in paragraph (d) of this section.

(2) No. 059130 for use of the powder described in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Horses—(i) Amount and indications for use—(A) For equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum, administer soluble powder described in paragraph (a)(1) of this section daily as a drench or as a top dressing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams.

(B) For treating ringworm infection caused by T. equinum, administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 bolus; and foals, one-half bolus.

(ii) Limitations. Not for use in horses intended for food.

* * * * *

Dated: June 23, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.