Withdrawal of Approval of Bayer Corporation’s
New Animal Drug Application (NADA) 140-828 (Baytril)
Docket No. 00N-1571

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

• causes 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 has requested a hearing regarding CVM's proposed withdrawal of approval.

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. 00N-1571, Enrofloxacin for Poultry: Withdrawal of Approval of Bayer Corporation’s New Animal Drug Application (NADA) 140-828 (Baytril).

CVM Updates/FDA News Releases

• 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

• Docket No. 00N-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. 00N-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 | html | | pdf |

• Notice of an Opportunity for a Hearing (NOOH) - Docket No. 00N-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 |

• (October 31, 2000): Docket No. 00N-1571, CVM 76. Enrofloxacin for Poultry; Opportunity For Hearing. Pages 64954-64965 [FR Doc. 27832] October 21, 2000 | htm | | pdf | Written comments by November 30, 2000

  • Risk Assessment (pdf)

Briefs

• 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

• 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

• 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

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

Withdrawal Process-Applicable Statutes, Regulations and Policies

• Federal Food, Drug and Cosmetic Act, As Amended --
  Chapter V - Drugs and Devices

• Subchapter A- Drugs and Devices
  Section 512 [360b]

• U.S. Code: Title 21 - Food and Drugs

  • Part 5.502 – Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications

  • Part 12 – Formal Evidentiary Public Hearing Issuance of Notices

  • 514.115 – Withdrawal of approval of applications

  • 514.116 – Notice of withdrawal of approval of application

  • 514.200 – Contents of notice of opportunity for a hearing

  • 514.201 – Procedures for hearings

• CVM Program Policy and Procedures Manual
  Guide 1240.3670 - Management of Formal Evidentiary Hearings (pdf)

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