Certain Other Dosage Form New Animal Drugs; Progesterone Intravaginal Inserts
other · Food and Drug Administration · Rule · Published 2009-11-17 · Effective 2009-11-17 · 74 FR 59073
Document
Document number
E9-27497
Federal Register citation
74 FR 59073
CFR reference
21 CFR 529
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-11-17
Effective date
2009-11-17
HHS docket
Docket No. FDA-2009-N-0665
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 Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for use of a progesterone intravaginal insert for induction of estrus in ewes during seasonal anestrus.