Implantation or Injectable Dosage Form New Animal Drugs; Insulin
other · Food and Drug Administration · Rule · Published 2004-05-10 · Effective 2004-05-10 · 69 FR 25827
Document
Document number
04-10498
Federal Register citation
69 FR 25827
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-05-10
Effective date
2004-05-10
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of an injectable suspension of zinc insulin of porcine origin for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.