80_FR_18844 80 FR 18777 - Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole

80 FR 18777 - Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 67 (April 8, 2015)

Page Range18777-18777
FR Document2015-08024

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a fomepizole injectable solution used as an antidote for ethylene glycol poisoning in dogs. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.

Federal Register, Volume 80 Issue 67 (Wednesday, April 8, 2015) 
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Rules and Regulations]
[Page 18777]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2015-N-0002]


Implantation or Injectable Dosage Form New Animal Drugs; 
Withdrawal of Approval of New Animal Drug Application; Fomepizole

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) for a fomepizole injectable 
solution used as an antidote for ethylene glycol poisoning in dogs. 
This action is being taken at the sponsor's request because this 
product is no longer manufactured or marketed.

DATES: Withdrawal of approval is effective April 20, 2015.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9075, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Paladin Labs (USA), Inc., 160 Greentree Dr., 
suite 101, Dover, DE 19904 has requested that FDA withdraw approval of 
NADA 141-075 for ANTIZOL-VET (fomepizole) Injection because the product 
is no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of NADA 
141-075, and all supplements and amendments thereto, is hereby 
withdrawn.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of this application.

    Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-08024 Filed 4-7-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations 18777 Zilpaterol in Combination in grams/ton Indications for use Limitations Sponsor grams/ton * * * * * * * (9) 6.8 to 24 ....... Monensin 10 to 40, plus Heifers fed in confinement for slaughter: For Feed continuously to heifers 000061 tylosin 8 to 10, plus increased rate of weight gain, improved during the last 20 to 40 melengestrol acetate to feed efficiency, and increased carcass days on feed to provide 60 provide 0.25 to 0.5 mg/ leanness in cattle fed in confinement for mg zilpaterol hydrochloride head/day. slaughter during the last 20 to 40 days on per head per day. See feed; for prevention and control of coc- §§ 558.342(d), 558.355(d), cidiosis due to Eimeria bovis and E. and 558.625(c). Monensin zuernii; and for reduction of incidence of and tylosin as provided by liver abscesses caused by Fusobacterium No. 000986; melengestrol necrophorum and Arcanobacterium acetate as provided by No. (Actinomyces) pyogenes; and for sup- 054771 in § 510.600(c) of pression of estrus (heat). this chapter. Withdrawal period: 3 days. Dated: April 3, 2015. Therefore, under authority delegated ADDRESSES: EPA has established a Bernadette Dunham, to the Commissioner of Food and Drugs docket for this action under Docket ID Director, Center for Veterinary Medicine. and redelegated to the Center for No. EPA–HQ–RCRA–2015–0118. All [FR Doc. 2015–08025 Filed 4–7–15; 8:45 am] Veterinary Medicine, and in accordance documents in the docket are listed in BILLING CODE 4164–01–P with § 514.116 Notice of withdrawal of the www.regulations.gov index. approval of application (21 CFR Although listed in the index, some 514.116), notice is given that approval information is not publicly available, DEPARTMENT OF HEALTH AND of NADA 141–075, and all supplements e.g., Confidential Business Information HUMAN SERVICES and amendments thereto, is hereby (CBI) or other information whose withdrawn. disclosure is restricted by statute. Food and Drug Administration Elsewhere in this issue of the Federal Certain other material, such as Register, FDA is amending the animal copyrighted material, is not placed on 21 CFR Part 522 drug regulations to reflect the voluntary the internet and will be publicly withdrawal of approval of this available only in hard copy form. [Docket No. FDA–2015–N–0002] application. Publicly available docket materials are Dated: April 3, 2015. available either electronically through Implantation or Injectable Dosage www.regulations.gov or in hard copy at Form New Animal Drugs; Withdrawal Bernadette Dunham, the EPA Docket Center, EPA/DC, WJC of Approval of New Animal Drug Director, Center for Veterinary Medicine. West Building, Room 3334, 1301 Application; Fomepizole [FR Doc. 2015–08024 Filed 4–7–15; 8:45 am] Constitution Ave. NW., Washington, BILLING CODE 4164–01–P DC. The Public Reading Room is open AGENCY: Food and Drug Administration, HHS. from 8:30 a.m. to 4:30 p.m. Monday ACTION: Notification of withdrawal. through Friday, excluding legal ENVIRONMENTAL PROTECTION holidays. The telephone number for the SUMMARY: The Food and Drug AGENCY Public Reading Room is (202) 566–1744 Administration (FDA) is withdrawing and the telephone number for the RCRA approval of a new animal drug 40 CFR Parts 260 and 261 Docket is (202) 566–0270. application (NADA) for a fomepizole [EPA–HQ–RCRA–2015–0118; FRL_9923–12– FOR FURTHER INFORMATION CONTACT: injectable solution used as an antidote OSWER] Office of Resource Conservation and for ethylene glycol poisoning in dogs. Response to Vacaturs of the Recovery, Materials Recovery and Waste This action is being taken at the Comparable Fuels Rule and the Management Division, MC 5304P, sponsor’s request because this product Gasification Rule Environmental Protection Agency, 1200 is no longer manufactured or marketed. Pennsylvania Ave. NW., Washington, DATES: Withdrawal of approval is AGENCY: Environmental Protection DC 20460, Tracy Atagi, at (703) 308– effective April 20, 2015. Agency (EPA). 8672, (atagi.tracy@epa.gov) or Frank FOR FURTHER INFORMATION CONTACT: ACTION: Final rule. Behan, at (703) 308–8476, behan.frank@ Sujaya Dessai, Center for Veterinary epa.gov. Medicine (HFV–212), Food and Drug SUMMARY: The Environmental Protection Administration, 7519 Standish Pl., Agency (EPA) is revising regulations SUPPLEMENTARY INFORMATION: Rockville, MD 20855, 240–276–9075, associated with the comparable fuels Preamble Outline sujaya.dessai@fda.hhs.gov. exclusion and the gasification I. General Information asabaliauskas on DSK5VPTVN1PROD with RULES SUPPLEMENTARY INFORMATION: Paladin exclusion, originally issued by EPA under the Resource Conservation and II. Statutory Authority Labs (USA), Inc., 160 Greentree Dr., III. Which regulations is EPA removing? suite 101, Dover, DE 19904 has Recovery Act (RCRA). These revisions IV. Background on the Comparable Fuels requested that FDA withdraw approval implement vacaturs ordered by the Rule and the Gasification Rule of NADA 141–075 for ANTIZOL–VET United States Court of Appeals for the V. When will the final rule become effective? (fomepizole) Injection because the District of Columbia Circuit (D.C. VI. State Authorization product is no longer manufactured or Circuit), on June 27, 2014. VII. Statutory and Executive Order (EO) marketed. DATES: Effective April 8, 2015. Reviews VerDate Sep<11>2014 16:24 Apr 07, 2015 Jkt 235001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\08APR1.SGM 08APR1


Document Created: 2018-02-21 10:06:39
Document Modified: 2018-02-21 10:06:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of withdrawal.
DatesWithdrawal of approval is effective April 20, 2015.
ContactSujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9075, [email protected]
FR Citation80 FR 18777 
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