E6-22515. Implantation or Injectable Dosage Form New Animal Drugs; Atipamezole

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 supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA adds a claim for reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution for dogs.

DATES:

This rule is effective January 4, 2007.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed a supplement to NADA 141-033 for ANTISEDAN (atipamezole hydrochloride), an injectable solution approved for reversal of the sedative and analgesic effects of medetomidine hydrochloride in dogs. The supplemental NADA adds a claim for reversal of sedative and analgesic effects of dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution for dogs. The application is approved as of December 1, 2006, and the regulations are amended in 21 CFR 522.147 to reflect the approval and a current format.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and effectiveness data and information submitted to support approval of these applications 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(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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning December 1, 2006.

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 Parts 522

• 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 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

2. In § 522.147, revise the section heading and paragraphs (a) and (c) to read as follows:

§ 522.147

Atipamezole.

(a) Specifications. Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride.

(c) Conditions of use in dogs—(1) Amount. Inject intramuscularly the same volume as that of dexmedetomidine or medetomidine used.

(2) Indications for use. For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: December 19, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.