Implantation or Injectable Dosage Form New Animal Drugs; Ketamine Injection
other · US Department of Health and Human Services · Rule · Published 1995-09-25 · Effective 1995-09-25 · 60 FR 49339
Document
Document number
95-23600
Federal Register citation
60 FR 49339
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1995-09-25
Effective date
1995-09-25
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Fermenta Animal Health Co. The ANADA provides for intramuscular use of ketamine hydrochloride injection in cats for restraint and to produce anesthesia that is suitable for diagnostic or minor surgical procedures that do not require skeletal muscle relaxation and in nonhuman primates for restraint.