other · Food and Drug Administration · Rule · Published 2012-03-19 · Effective 2012-03-19 · 77 FR 15960
Document
Document number
2012-6544
Federal Register citation
77 FR 15960
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-03-19
Effective date
2012-03-19
HHS docket
Docket No. FDA-2011-N-0003
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 the veterinary prescription use of pergolide mesylate tablets in horses for the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).