April 18, 2007
First FDA Conditionally Approved New Animal Drug for Columnaris Disease in Catfish
The U.S. Food and Drug Administration (FDA) is announcing the conditional approval of Aquaflor®-CA1 (florfenicol) Type A medicated article for the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare. Aquaflor®-CA1 is the first FDA conditionally approved drug for columnaris disease in catfish. Aquaflor®-CA1 is also the first drug that FDA has conditionally approved under the Minor Use and Minor Species (MUMS) Animal Health Act.
Columnaris disease is a major bacterial disease of catfish in the
The “CA1” in the product name indicates that the drug is conditionally approved (CA) and that this is the first (1) conditionally approved application for this formulation. In addition, the product labeling includes a specific statement required by the MUMS Act, “Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-259.”
The FDA reviewed extensive data to ensure the product met all necessary target animal safety, environmental safety, and human food safety standards, including with respect to antimicrobial resistance. The FDA concluded that catfish fed florfenicol are safe for human consumption when florfenicol is administered according to the label directions. FDA also concluded that the data submitted demonstrated that there is a reasonable expectation that Aquaflor®-CA1 is effective for columnaris disease in catfish.
Conditional approval allows the sponsor to market a drug before collecting all necessary effectiveness data as long as the sponsor has demonstrated that there is a reasonable expectation that the drug is effective. The sponsor may continue marketing Aquaflor®-CA1 for up to five years, subject to annual renewals, while collecting substantial evidence of effectiveness.
Aquaflor®-CA1 is a veterinary feed directive drug, meaning that the medicated feed can only be fed on the order of a licensed veterinarian. The extra-label or off label use of medicated feed containing florfenicol is prohibited.
Aquaflor®-CA1 has been declared a designated new animal drug by FDA under the designation provision of the MUMS Act. This entitles Aquaflor®-CA1 to seven years of exclusive marketing rights beginning on the date of conditional approval.
Aquaflor®-CA1 is a product of Schering-Plough Animal Health Corporation,
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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