Aquaculture drug is first conditionally approved drug to transition to full approval
April 9, 2012
The U.S. Food and Drug Administration announced today the approval of Aquaflor (florfenicol) Type A medicated article and the end of the 5-year marketing period for the conditionally approved Aquaflor-CA1 (florfenicol) Type A medicated article. The approval of Aquaflor adds two new indications, increases the maximum florfenicol dose for a previously approved indication, and establishes a single withdrawal period for all approved uses. The new indications are:
- Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae
- Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare
Both diseases are associated with significant losses in U.S. aquaculture.
This approval marks the first transition of a conditionally approved indication to a fully approved product. The conditionally approved indication for columnaris disease in catfish is a subset of the columnaris disease indication for freshwater-reared finfish that is now fully approved.
With this approval, the maximum florfenicol dose that may be administered to catfish for the previously approved enteric septicemia of catfish indication has increased to 15 mg/kg body weight/day providing a dose range of 10-15 mg/kg body weight/day. With the increase in the maximum florfenicol dose that may be administered to catfish and the addition of the new indications, the withdrawal period for catfish has been lengthened from 12 days to 15 days. Aquaflor now has a single withdrawal period of 15 days for all approved uses.
Aquaflor is a veterinary feed directive drug, which means that the medicated feed can only be fed on the order of a licensed veterinarian. The extra-label use of medicated feed manufactured with Aquaflor is strictly prohibited.
FDA reviewed extensive data to ensure the product met all necessary effectiveness, target animal safety, human food safety, environmental safety, and manufacturing standards. FDA has concluded that freshwater-reared finfish fed florfenicol according to the label directions are safe for human consumption.
Commercially available feeds are commonly used to prepare medicated feeds for use in freshwater-reared finfish species. Consequently, in current practice, feeds having the same or similar composition as salmonid or catfish feeds are often used to deliver an approved new animal drug to non-salmonid and non-catfish freshwater-reared finfish species while meeting the nutritional requirements of these finfish species. Because the nutritional composition of feeds may affect characteristics such as the mixing, stability, and accuracy of assay of drugs they contain, an evaluation of these characteristics was performed. The evaluation of florfenicol for use in freshwater-reared finfish was performed on catfish and salmonid feeds that varied in some common nutritional parameters; lipids and protein ranged from 5 to 25% and from 28.5 to 55%, respectively.
This approval of Aquaflor is the result of cooperation between the pharmaceutical company, Intervet, Inc., and public sector researchers. The following government groups generated and contributed data for the approval: U.S. Fish and Wildlife Service, Aquatic Animal Drug Approval Partnership Program, Bozeman, MT; U.S. Department of Agriculture, Agricultural Research Service, Stuttgart National Aquaculture Research Center, Stuttgart, AR; U.S. Geologic Survey, Upper Midwest Environmental Sciences Center, La Crosse, WI; Florida Fish and Wildlife Conservation Commission, Florida Bass Conservation Center, Webster, FL; Mississippi State University, Thad Cochran National Warmwater Aquaculture Center, Stoneville, MS; and Washington Department of Fish and Wildlife, Bellingham State Fish Hatchery, Bellingham, WA.
Aquaflor is a product of Intervet, Inc., Summit, New Jersey. For certain indications, Aquaflor is designated under the Minor Use and Minor Species Animal Health Act of 2004, which entitles Intervet, Inc. to seven years of exclusive marketing rights for these indications beginning on the date of approval.