Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin
other · Food and Drug Administration · Rule · Published 2002-12-27 · Effective 2002-12-27 · 67 FR 78972
Document
Document number
02-32747
Federal Register citation
67 FR 78972
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-12-27
Effective date
2002-12-27
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 the veterinary prescription use of danofloxacin solution in cattle, by subcutaneous injection, for treatment of bovine respiratory disease associated with Mannheimia (Pasteurella) haemolytica and Pasteurella multocida. FDA is also amending the regulations to add the acceptable daily intake for total residues of danofloxacin and tolerances for residues of danofloxacin in edible tissues of cattle.