Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium Injection
other · Food and Drug Administration · Rule · Published 2006-01-11 · Effective 2006-01-11 · 71 FR 1689
Document
Document number
06-229
Federal Register citation
71 FR 1689
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-01-11
Effective date
2006-01-11
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 Bayer HealthCare LLC. The supplemental NADA provides for veterinary prescription use of a hyaluronate sodium solution, formulated with a benzyl alcohol preservative, for intravenous administration to horses for the treatment of osteoarthritis.