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The Final Decision of the FDA Commissioner, dated July 27, 2005, ordered the approval for NADA 140-828, be withdrawn pursuant to § 512(e)(1)(B) of the Food Drug and Cosmetic Act.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).
Federal Register Notices
- Notice: Enrofloxacin for Poultry; Final Decision on Withdrawal of New Animal Drug Application Following Formal Evidentiary Public Hearing; Availability
- Final Rule: Animal Drugs, Feeds, and Related Products; Enrofloxacin for Poultry; Withdrawal of Approval of New Animal Drug Application
- Notice: Enrofloxacin for Poultry; Notice of Hearing
- Final Rule: Animal Drugs, Feeds, and Related Products; Sarafloxacin for Poultry; Withdrawal of Approval of NADAs
- Notice: Abbott Laboratories' Sarafloxacin for Poultry; Withdrawal of Approval of NADAs
- Notice; Correction: Enrofloxacin for Poultry; Opportunity for Hearing; Correction
- Notice: Enrofloxacin for Poultry; Opportunity For Hearing
- Narrative Statement of the Director of CVM Pursuant to 21 CFR 12.85 on the Proposal to Withdraw Enrofloxacin (NADA 140-828) for Use in Poultry (PDF - 31KB)
- Human Health Impact of Fluoroquinolone Resistant Campylobacter Attributed to the Consumption of Chicken (PDF - 1.1MB)
Briefs and 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
- Initial Decision - Enrofloxacin for Poultry
- Final Decision - Enrofloxacin for Poultry (Part 1)
- Final Decision - Enrofloxacin for Poultry (Part 2)
- Petition - McDermott Will & Emery (PDF - 142KB)
- Response - McDermott Will & Emery (PDF - 84KB)
- Petition - Animal Health Institute (PDF - 370KB)
- Response - Animal Health Institute (PDF - 138KB)
- Petition - American College of Poultry Veterinarians (PDF - 926KB)