Table of Contents

CVM Updates/FDA News
FR Notices
Briefs
Additional Information
Withdrawal
Enrofloxacin for Poultry

Withdrawal of Approval of Bayer Corporation’s
New Animal Drug Application (NADA) 140-828 (Baytril)
Docket No. 2000N-1571 *

The Center for Veterinary Medicine (CVM) proposed the withdrawal of fluoroquinolones in poultry water. The Center determined that the use of fluoroquinolones in poultry:

• caused the development of fluoroquinolone-resistant Campylobacter species in poultry,

• that these fluoroquinolone-resistant organisms are transferred to humans and cause the development of fluoroquinolone-resistant Campylobacter in humans,

• and fluoroquinolone-resistant Campylobacter infections in humans are a health hazard.

Included in the class of antimicrobials known as fluoroquinolones is enrofloxacin; ciprofloxacin is the comparable human drug in this class. Baytril, the trade name of enrofloxacin, is indicated for the control, in chickens, of mortality associated with Escherichia coli (E.coli) and in turkeys, of mortality associated with E.coli and Pasterella multocida. Baytril is the product of Bayer Corp., Shawnee Mission, KS, which requested a hearing regarding CVM's proposed withdrawal of approval.

The Final Decision of the FDA Commissioner, dated July 27, 2005, ordered the approval for NADA 140-828, be withdrawn pursuant to § 512(e)(1)(B) of the Food Drug and Cosmetic Act.  The order is effective September 12, 2005.

Selected Food and Drug Administration (FDA) documents addressing the enrofloxacin for poultry withdrawal are posted on this page. For all of the documents on this withdrawal please visit Dockets and search for Docket No. 2000N-1571, Enrofloxacin for Poultry: Withdrawal of Approval of Bayer Corporation’s New Animal Drug Application (NADA) 140-828 (Baytril).

CVM Updates/FDA News Releases

• FDA News - FDA Announces Final Decision About Veterinary Medicine, July 28, 2005

• CVM Update - Initial Decision on Proposed Withdrawal of Baytril Poultry NADA, March 18, 2004

• FDA Talk Paper - FDA to Hold Public Hearing on Proposal to Withdraw Poultry Antimicrobial Approval, February 20, 2002

• CVM Update - Deadline Extended for Submitting Data for Poultry Fluoroquinolone NOOH, January 5, 2001

• CVM Update - FDA/CVM Proposes to Withdraw Poultry Fluoroquinolones Approval, October 26, 2000

Federal Register Notices

• NOTICES
  Docket No. 2000N-1571, OC 2005193.  Enrofloxacin for Poultry; Final Decision on Withdrawal of New Animal Drug Application Following Formal Evidentiary Public Hearing; Availability.  Page  44105 [FR Doc. 05-15224]  August 1, 2005 | htm | | pdf |

• FINAL RULES
  Docket No. 2000N-1571, OC 2005194.  Animal Drugs, Feeds, and Related Products; Enrofloxacin for Poultry; Withdrawal of Approval of New Animal Drug Application.  Pages  44048-44049 [FR Doc. 05-15223]  August 1, 2005 | htm | | pdf | Effective on September 12, 2005

• Docket No. 2000N-1571, CVM 2001115. Enrofloxacin for Poultry; Notice of Hearing. Pages 7700-–7701 [FR Doc. 02-04082 ] February 20, 2002 | htm | pdf | Written notice of participation by March 22, 2002 Prehearing conference - cancelled April 8, 2002

  • Narrative Statement (pdf)

  • Narrative Statement (rtf)

• NADA 141-017, CVM 2000100. Animal Drugs, Feeds, and Related Products; Sarafloxacin for Poultry; Withdrawal of Approval of NADAs. Page 21282 [FR Doc. 01-10069] April 30, 2001 | htm | | pdf |

• NADA 141-017, Docket No. 01N-0170, CVM 200099. Abbott Laboratories’ Sarafloxacin for Poultry; Withdrawal of Approval of NADAs. Pages 21400-21401 [FR Doc. 01-10067] April 30, 2001 | htm | | pdf |

• Docket No. 2000N-1571, CVM 11. Enrofloxacin for Poultry; Opportunity for Hearing; Correction. Pages 6623-6624 [FR Doc. 01-1866] January 22, 2001. Written comments by February 21, 2001 | htm | | pdf |

• Notice of an Opportunity for a Hearing (NOOH) - Docket No. 2000N-1571, CVM 76. Enrofloxacin for Poultry; Opportunity for Hearing. Pages 64954-64965 [FR Doc. 27832] October 31, 2001 Written comments by January 2, 2001 | htm | | pdf |

• Docket No. 2000N-1571, CVM 76. Enrofloxacin for Poultry; Opportunity for Hearing. Pages 64954-64965 [FR Doc. 27832] October 31, 2000 | htm | | pdf | Written comments by November 30, 2000

  • Risk Assessment (pdf)

Briefs/Decisions

• Commissioner's decisions on the three petitions for stay of the Final Decision and Order filed in Docket No. 2000N-1571 on August 26, 2005

  • McDermott Will & Emery – Petition ; Response (pdf)

  • o Animal Health Institute – Petition ; Response (pdf)

  • American College of Poultry Veterinarians – Petition ; Response (pdf)

• Final Decision of the Commissioner, Docket Number 2000N-1571 - Withdrawal of Approval the New Animal Drug Application for Enrofloxacin in Poultry, July 27, 2005 (pdf)

• Initial Decision, Docket 2000N-1571, Proposal to Withdraw Approval of the New Animal Drug Application for Enrofloxacin for Poultry, March 16, 2004 (pdf)

• Center for Veterinary Medicine's Reply to Animal Health Institute's Post-Hearing Brief in the Matter of Enrofloxacin for Poultry: Withdrawal of Approval of New Animal Drug Application (NADA) 140-828 (Baytril), August 15, 2003 (pdf)

• Center for Veterinary Medicine's Reply to Bayer's Post-Hearing Brief in the Matter of Enrofloxacin for Poultry: Withdrawal of Approval of New Animal Drug Application (NADA) 140-828 (Baytril), August 15, 2003 (pdf)

• Center for Veterinary Medicine's Post Hearing Brief in Support of its Proposal to Withdraw Approval of the New Animal Drug Application for Enrofloxacin (Baytril): NADA 140-828, July 18, 2003 (pdf)

Additional Information

• Updated Information on FDA's Proposed Withdrawal of Approval of Poultry Fluoroquinolones, September 2003 

• Risk Assessment Human Health Impact of Fluoroquinolone Resistant Campylobacter Associated with the Consumption of Chicken, dated October 18, 2000, revised as of January 5, 2001

• CDC NARMS

• USDA NARMS

* formerly Docket Number 00N-1571

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