Conditionally Approved New Animal Drugs for Minor Use and Minor Species; Masitinib
other · Food and Drug Administration · Rule · Published 2012-06-15 · Effective 2012-06-15 · 77 FR 35837
Document
Document number
2012-14635
Federal Register citation
77 FR 35837
CFR reference
21 CFR 516
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-06-15
Effective date
2012-06-15
HHS docket
Docket No. FDA-2012-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a conditionally approved supplemental application for conditional approval of a new animal drug (CNADA) intended for a minor use filed by AB Science. The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs.