Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin
other · Food and Drug Administration · Rule · Published 2011-11-25 · Effective 2011-11-25 · 76 FR 72619
Document
Document number
2011-30328
Federal Register citation
76 FR 72619
CFR reference
21 CFR 524
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-11-25
Effective date
2011-11-25
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 a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for addition of a warning statement against the use of eprinomectin topical solution in preruminating calves intended for veal.