E6-22510. Implantation or Injectable Dosage Form New Animal Drugs; Doxapram

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 Modern Veterinary Therapeutics, LLC. The ANADA provides for the use of doxapram hydrochloride injectable solution in dogs, cats, and horses to stimulate respiration during and after general anesthesia.

DATES:

This rule is effective January 4, 2007.

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:

Modern Veterinary Therapeutics, LLC, 18301 SW. 86th Ave., Miami, FL 33157, filed ANADA 200-435 that provides for use of RESPIRAM (doxapram hydrochloride), an injectable solution, in dogs, cats, and horses to stimulate respiration during and after general anesthesia. Modern Veterinary Therapeutics, LLC's RESPIRAM is approved as a generic copy of DOPRAM-V Injectable, sponsored by Fort Dodge Animal Health, Division of Wyeth, under NADA 034 879. The ANADA is approved as of November 21, 2006, and the regulations are amended in 21 CFR 522.775 to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary.

In addition, Modern Veterinary Therapeutics, LLC, has not been previously listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for this firm.

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

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

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 parts 510 and 522 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 510.600, in the table in paragraph (c)(1), alphabetically add a new entry for “Modern Veterinary Therapeutics, LLC”; and in the table in paragraph (c)(2) numerically add a new entry for “015914” to read as follows:

§ 510.600

Names, addresses, and drug labeler codes of sponsors of approved applications.

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*    *    *    *    *
Modern Veterinary Therapeutics, LLC, 18301 SW. 86th Ave., Miami, FL 33157	015914
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
015914	Modern Veterinary Therapeutics, LLC, 18301 SW. 86th Ave., Miami, FL 33157
*    *    *    *    *

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

4. Revise § 522.775 to read as follows:

§ 522.775

Doxapram.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) doxapram hydrochloride.

(b) Sponsor. See Nos. 000856 and 015914 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. For intravenous use in dogs and cats at a dose of 21/2 to 5 mg per pound (/lb) body weight in barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for intravenous use in horses at 0.25 mg/lb body weight in barbiturate anesthesia, 0.2 mg/lb in inhalation anesthesia, 0.25 mg/lb with chloral hydrate with or without magnesium sulfate; for subcutaneous, sublingual, or umbilical vein administration in neonate puppies at a dose rate of 1 to 5 mg; for subcutaneous or sublingual use in neonate kittens at 1 to 2 mg. Dosage may be repeated in 15 to 20 minutes if necessary.

(2) Indications for use. Administer to dogs, cats, and horses to stimulate respiration during and after general anesthesia; or to speed awakening and return of reflexes after anesthesia. Administer to neonate dogs and cats to initiate respiration following dystocia or caesarean section; or to stimulate respiration following dystocia or caesarean section.

(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.