Initial Decision on Proposed Withdrawal of Baytril Poultry NADA

March 18, 2004

FDA Administrative Law Judge Daniel J. Davidson issued his initial decision on the Center for Veterinary Medicine's (CVM's) proposal to withdraw approval of the new animal drug application (NADA) for enrofloxicin for poultry on March 16, 2004. The brand name of enrofloxicin for poultry is Baytril 3.23%, and the product sponsor is Bayer Animal Health.

Judge Davidson ordered that the approval of the NADA for that drug for use in poultry be withdrawn, effective on the date the initial decision becomes final. This initial decision will become the final decision of the Commissioner by operation of law in the absence of the timely filing of exceptions by any participant or the filing of a notice that the Commissioner intends to review the decision.

CVM proposed withdrawing the approval of the new animal drug application of Baytril 3.23% Concentrate Antimicrobial Solution in October 2000, when CVM issued a notice of opportunity for hearing giving the drug sponsor an opportunity to respond and to request a hearing on the safety of the product. Bayer requested a hearing on this matter, and the hearing was held in front of Judge Davidson on April 28, 2003 - May 7, 2003.

A link to Judge Davidson's decision may be found on the FDA Home Page.