other · Food and Drug Administration · Rule · Published 2009-09-17 · Effective 2009-09-17 · 74 FR 47725
Document
Document number
E9-22384
Federal Register citation
74 FR 47725
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-09-17
Effective date
2009-09-17
HHS docket
Docket No. FDA-2009-N-0665
Abstract
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.