2010-16301. Implantation or Injectable Dosage Form New Animal Drugs; Propofol

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 (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of propofol as an anesthetic in dogs and cats.

DATES:

This rule is effective July 6, 2010.

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, email: [e-mail].

SUPPLEMENTARY INFORMATION:

Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 filed NADA 141-303 that provides for veterinary prescription use of PROPOCLEAR (propofol) in dogs and cats for induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic. The application is approved as of May 21, 2010, and the regulations are amended in 21 CFR 522.2005 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 a.m. and 4 p.m., Monday through Friday.

The agency 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.

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

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. In § 522.2005, revise paragraphs (b) and (c) to read as follows:

§ 522.2005

Propofol.

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

(1) No. 059130 for use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section.

(2) No. 000074 for use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section.

(3) No. 000856 for use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section.

(c) Conditions of use in dogs and cats—(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.

(2) Indications for use—(i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; for induction of general anesthesia where maintenance is provided by inhalant anesthetics.

(ii) For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic.

Dated: June 29, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.