Implantation or Injectable Dosage Form New Animal Drugs; Insulin
other · Food and Drug Administration · Rule · Published 2009-12-14 · Effective 2009-12-14 · 74 FR 66047
Document
Document number
E9-29583
Federal Register citation
74 FR 66047
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-12-14
Effective date
2009-12-14
HHS docket
Docket No. FDA-2009-N-0665
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for veterinary prescription use of an injectable suspension of protamine zinc recombinant human insulin for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.