Implantation or Injectable Dosage Form New Animal Drugs; Deslorelin Acetate
other · Food and Drug Administration · Rule · Published 1998-08-19 · Effective 1998-08-19 · 63 FR 44382
Document
Document number
98-22224
Federal Register citation
63 FR 44382
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-08-19
Effective date
1998-08-19
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Peptech Animal Health Pty, Ltd. The NADA provides for veterinary prescription use of deslorelin acetate implants in horses and ponies for inducing ovulation in estrous mares with an ovarian follicle greater than 30 millimeters (mm) in diameter.