Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine
other · Food and Drug Administration · Rule · Published 2010-09-30 · Effective 2010-09-30 · 75 FR 60307
Document
Document number
2010-24494
Federal Register citation
75 FR 60307
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-09-30
Effective date
2010-09-30
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a preanesthetic to general anesthesia in cats.