New Animal Drugs; Change of Sponsor: Fomepizole

Federal Register: June 5, 2009 (Volume 74, Number 107)

Rules and Regulations

Page 26951-26952

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr05jn09-5

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Parts 510 and 522

Docket No. FDA-2009-N-0665

New Animal Drugs; Change of Sponsor; 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 a change of sponsor for a new animal drug application (NADA) for fomepizole solution for injection from Jazz

Pharmaceuticals, Inc., to Paladin Labs (USA), Inc.

DATES: This rule is effective June 5, 2009.

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: david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Jazz Pharmaceuticals, Inc., 3180 Porter Dr.,

Palo Alto, CA 94304, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-075 for ANTIZOL-VET

(fomepizole) to Paladin Labs (USA), Inc., 160 Greentree Dr., suite 101,

Dover, DE 19904. Accordingly, the agency is amending the regulations in 21 CFR 522.1004 to reflect the transfer of ownership.

Following these changes of sponsorship, Jazz Pharmaceuticals, Inc., is no longer the sponsor of an approved application. Accordingly, 21

CFR 510.600(c) is being amended to remove the entries for this sponsor.

In addition, Paladin Labs (USA), Inc., 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.

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. 0

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

Page 26952

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 0 2. In Sec. 510.600, in the table in paragraph (c)(1) remove the entry for ``Jazz Pharmaceuticals, Inc.'' and alphabetically add a new entry for ``Paladin Labs, Inc.''; and in the table in paragraph (c)(2) remove the entry for ``068727'' and numerically add a new entry for ``046129'' to read as follows:

Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address

Drug labeler code

* * * * *

Paladin Labs (USA), Inc., 160 Greentree Dr., 046129 suite 101, Dover, DE 19904

* * * * *

(2) * * *

Drug labeler code

Firm name and address

* * * * * 046129

Paladin Labs (USA), Inc., 160 Greentree

Dr., suite 101, Dover, DE 19904

* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for 21 CFR part 522 continues to read as follows:

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

Sec. 522.1004 [Amended] 0 4. In paragraph (b) of Sec. 522.1004, remove ``068727'' and add in its place ``046129''.

Dated: June 1, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

FR Doc. E9-13126 Filed 6-4-09; 8:45 am

BILLING CODE 4160-01-S