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Table of Contents
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This page contains safety information on drug products regulated by the FDA Center for Veterinary Medicine (CVM). Additional safety information on products regulated by CVM or the FDA can be found on the CVM Product Safety Information Page.
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FDA Database of Approved Animal Drug Products
You can search this database for approval information, including indications and withdrawal times about animal drugs.
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Freedom of Information (FOI Summaries)
The FOI Summary summarizes the safety and effectiveness information submitted by the drug sponsor to support the approval of an original or supplemental NADA. The indications for use, dosage form, route of administration, and the recommended dosage are explained.
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Current Labels and Client Information Sheets
A select list of current drug package labels and product information inserts provided by drug manufacturers.
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Adverse Drug Experience Reporting
Veterinarians and animal owners are encouraged to report Veterinary Adverse Drug Experiences (ADEs) and suspected product failures to the government Agency that regulates the product in question. Pre-approval testing by the manufacturer and review of the data by the government does not guarantee absolute safety and effectiveness of approved veterinary drugs due to the inherent limitations imposed by testing the product under experimental conditions on a limited population of animals. Anyone with information to report is also encouraged to contact the manufacturer of the suspect product.
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Dear Doctor Letters for Animal Drugs
Letters issued to veterinary medicine professionals by drug manufacturers alerting the professionals to important safety information.
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Deramaxx, Novartis Animal Health US, December 22, 2003
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ProHeart®6, Fort Dodge Animal Health, June 19, 2003 | pdf |
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ProHeart®6, Fort Dodge Animal Health, July 22, 2002 | pdf |
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Baytril®, Bayer Corporation, July 6, 2000 | pdf |
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EtoGesic®, Tablets, Fort Dodge Animal Health, May 23, 2000 | pdf |
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RIMADYL®, Pfizer, Inc., March 9, 2000 | pdf |
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Notice of Regulatory Activity Letters to Pharmaceutical Companies
Supplied by the CVM Freedom of Information Staff, these are the regulatory activity letters issued by the Division of Surveillance, Office of Surveillance and Compliance.
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Other Safety Notifications
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News - CVM Updates/HHS/FDA News Releases related to animal drugs
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CVM Update - FDA Extends Cephalosporin Comment Period and Delays Final Rule, August 15, 2008
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CVM Update - FDA Issues Order Prohibiting Extralabel Use of Cephalosporin Antimicrobial Drugs in Food-Producing Animals, July 2, 2008
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CVM Update - COMFORTIS® and ivermectin interaction Safety Warning Notification, June 24, 2008
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CVM Update - CVM announces the Return of Fort Dodge Animal Health’s ProHeart® 6, June 5, 2008
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FDA News - More than $300,000 of Drugs and Dietary Supplements Seized, November 1, 2007
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CVM Update - FDA Reminds Veterinarians on the Correct Use of Flunixin Meglumine, May 10, 2007
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CVM Update - Reminder to Aquaculture Producers about the Use of Formaldehyde, June 23, 2006
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FDA News - FDA Announces Final Decision About Veterinary Medicine, July 28, 2005
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FDA Talk Paper - Fort Dodge to Comply with FDA's Request to Recall ProHeart6 Injectable Heartworm Product from the Market Due to Serious Health Concerns, September 3, 2004
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FDA Talk Paper - FDA Recommended Seizure on Illegal Horse Drugs Carried Out by United States Marshals Under Court Order, August 12, 2004
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CVM Update - Environmental Warning Added to Animal Euthanasia Products, July 22, 2003
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CVM Update - FDA Prohibits Nitrofuran Drug Use in Food-Producing Animals, February 7, 2002
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CVM Update - Update on Illegal Compounding of Clenbuterol Veterinary Drug Products, January 10, 2002
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FDA Talk Paper - FDA Stops Importation and Distribution of Contaminated Animal Drugs, March 12, 1999
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HHS News - Contaminated Veterinary Drugs, January 16, 1998
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FDA Enforcement Report Index (Recalls and Legal Actions)
The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities, including all FDA-classified recalls.
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FDA’s Product Recalls, Alerts, and Warnings
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority. In addition, to provide better service in alerting the American people to unsafe, hazardous or defective products, six federal agencies with vastly different jurisdictions have joined together to create http://www.recalls.gov/ – a “one stop shop” for U.S. Government recalls at Recalls.gov.
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Guidance Documents
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Judicious Use of Antimicrobials
Judicious use of therapeutic antimicrobials is an integral part of good veterinary practice. It is an approach to maximize therapeutic efficacy and minimize selection of resistant microorganisms.
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Withdrawal of New Animal Drug Applications Process
The applicable statutes, regulations and policies CVM follows when it proposes the withdrawal of approval of new animal drug applications for the reason of the safety and effectiveness of drugs.
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Animal Drug Safety FAQ’s
Web Page Updated by hd - August 15, 2008, 1:33 PM ET
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