2010-8945. Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; 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 a change of sponsor for a new animal drug application (NADA) from Intervet, Inc., to Teva Animal Health, Inc.

DATES:

This rule is effective April 19, 2010.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 141-070 for RAPINOVET (propofol), an injectable anesthetic, to Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503. Accordingly, the agency is amending the regulations in 21 CFR 522.2005 to reflect the transfer of ownership and a current format.

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 § 522.2005 to read as follows:

§ 522.2005

Propofol.

(a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) propofol.

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

(1) No. 059130 for use as in paragraph (c) of this section.

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

(c) Conditions of use in dogs and cats—(1) Amount. The drug is administered by intravenous injection as follows:

(i) Dogs. For induction of general anesthesia without the use of preanesthetics the dosage is 5.5 to 7.0 mg per kilogram (mg/kg) (2.5 to 3.2 mg/pound (lb)); for the maintenance of general anesthesia without the use of preanesthetics the dosage is 1.1 to 3.3 mg/kg (0.5 to 1.5 mg/lb). The use of preanesthetic medication reduces propofol dose requirements.

(ii) Cats. For induction of general anesthesia without the use of preanesthetics the dosage is 8.0 to 13.2 mg/kg (3.6 to 6.0 mg/lb). For the maintenance of general anesthesia without the use of preanesthetics the dosage is 1.1 to 4.4 mg/kg (0.5 to 2.0 mg/lb). The use of preanesthetic medication reduces propofol dose requirements.

(2) Indications for use. 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.

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

Dated: April 13, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.