Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole
other · Food and Drug Administration · Rule · Published 2015-04-08 · Effective 2015-04-20 · 80 FR 18777
Document
Document number
2015-08024
Federal Register citation
80 FR 18777
CFR reference
21 CFR 522
Type
Rule
Action
Notification of withdrawal.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-04-08
Effective date
2015-04-20
HHS docket
Docket No. FDA-2015-N-0002
Abstract
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.