Oral Dosage Form New Animal Drugs; Carprofen Caplets
other · US Department of Health and Human Services · Rule · Published 1996-12-18 · Effective 1996-12-18 · 61 FR 66581
Document
Document number
96-32068
Federal Register citation
61 FR 66581
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-12-18
Effective date
1996-12-18
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 Pfizer, Inc. The NADA provides for oral use of nonsteroidal anti-inflammatory carprofen caplets in dogs for relief of pain and inflammation. Carprofen has been shown to be clinically effective for the relief of signs associated with osteoarthritis.