Document ID: FDA-2015-N-0002-0002
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal
of Approval of New Animal Drug Application; Fomepizole
Posted Date: 2015-04-08T04:00Z

[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Rules and Regulations]
[Page 18777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08024]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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withdrawn.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