Implantation or Injectable Dosage Form New Animal Drugs; Desoxycorticosterone Pivalate
other · Food and Drug Administration · Rule · Published 1998-03-18 · 63 FR 13121
Document
Document number
98-6911
Federal Register citation
63 FR 13121
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-03-18
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 Novartis Animal Health US, Inc. The NADA provides for use of desoxycorticosterone pivalate as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.