Implantation or Injectable Dosage Form New Animal Drugs; Polysulfated Glycosaminoglycan
other · US Department of Health and Human Services · Rule · Published 1996-10-18 · Effective 1996-10-18 · 61 FR 54333
Document
Document number
96-26686
Federal Register citation
61 FR 54333
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-10-18
Effective date
1996-10-18
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 Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for intramuscular (i.m.) use of polysulfated glycosaminoglycan in horses for the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the hock joint.