Department of Health and Human Services February 12, 2007 – Federal Register Recent Federal Regulation Documents
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Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin.
Voluntary Self Inspection of Medicated Feed Manufacturing Facilities; Draft Compliance Policy Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft compliance policy guide (CPG) entitled ``Voluntary Self Inspection of Medicated Feed Manufacturing Facilities.'' This draft CPG is intended to provide guidance to the FDA field offices in prioritizing inspections of medicated feed manufacturing facilities for compliance with Current Good Manufacturing Practices for Medicated Feeds regulations (CGMP).
Oral Dosage Form New Animal Drugs; Fluoxetine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of fluoxetine hydrochloride chewable tablets for the treatment of canine separation anxiety.
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