other · Food and Drug Administration · Rule · Published 2009-05-11 · Effective 2009-05-11 · 74 FR 21767
Document
Document number
E9-10927
Federal Register citation
74 FR 21767
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-05-11
Effective date
2009-05-11
HHS docket
Docket No. FDA-2009-N-0665
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of trilostane capsules in dogs for treatment of pituitary-dependent hyperadrenocorticism and for treatment of hyperadrenocorticism due to adrenocortical tumor.