E9-22384. New Animal Drugs; Fomepizole

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.

DATES:

This rule is effective September 17, 2009.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Synerx Pharma, LLC, 100 N. State St., Newtown, PA 18940-2048, filed ANADA 200-472 that provides for veterinary prescription use of Fomepizole for Injection as an antidote for ethylene glycol (antifreeze) poisoning in dogs. Synerx Pharma, LLC's Fomepizole for Injection is approved as a generic copy of Paladin Laboratories' ANTIZOL-VET (fomepizole), approved under NADA 141-075. The ANADA is approved as of 2009, and the regulations are amended in 21 CFR 522.1004 to reflect the approval.

In addition, Synerx Pharma, LLC, is not currently 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 sponsor.

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 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 an entry for “Synerx Pharma, LLC”; and in the table in paragraph (c)(2), numerically add an entry for “068882” 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
*    *    *    *    *
Synerx Pharma, LLC, 100 N. State St., Newtown, PA 18940-2048	068882
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
068882	Synerx Pharma, LLC, 100 N. State St., Newtown, PA 18940-2048
*    *    *    *    *

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. In § 522.1004, revise paragraph (b) to read as follows:

§ 522.1004

Fomepizole.

(b) Sponsors. See Nos. 068727 and 068882 in § 510.600(c) of this chapter.

Dated: September 14, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.