E6-18444. Implantation or Injectable Dosage Form New Animal Drugs; Glycopyrrolate

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 an abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of glycopyrrolate solution as an injectable preanesthetic agent in dogs and cats.

DATES:

This rule is effective November 2, 2006.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV 104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200-365 that provides for veterinary prescription use of Glycopyrrolate Injectable as a preanesthetic agent in dogs and cats. IVX Animal Health, Inc.'s Glycopyrrolate Injectable is approved as a generic copy of Fort Dodge Animal Health's, Division of Wyeth's ROBINUL-V (glycopyrrolate), approved under NADA 101-777. The ANADA is approved as of October 2, 2006, and the regulations are amended in 21 CFR 522.1066 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.

FDA 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 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. Revise § 522.1066 to read as follows:

§ 522.1066

Glycopyrrolate.

(a) Specifications. Each milliliter of solution contains 0.2 milligram glycopyrrolate.

(b) Sponsors. See Nos. 000856 and 059130 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. 5 micrograms per pound of body weight (0.25 milliliter per 10 pounds of body weight) by intravenous, intramuscular, or subcutaneous injection in dogs or by intramuscular injection in cats.

(2) Indications for use. As a preanesthetic agent.

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

Dated: October 23, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.