Implantation or Injectable Dosage Form New Animal Drugs; Amikacin Sulfate Injection
other · Food and Drug Administration · Rule · Published 1997-04-30 · Effective 1997-04-30 · 62 FR 23357
Document
Document number
97-11085
Federal Register citation
62 FR 23357
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-04-30
Effective date
1997-04-30
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 Phoenix Scientific, Inc. The ANADA provides for the use of amikacin sulfate injection for the treatment of the following conditions in dogs: genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus spp. and skin and soft tissue infections caused by susceptible strains of Pseudomonas spp. and E. coli.