The U.S. Food and Drug Administration approved Paqflor (florfenicol), the first generic florfenicol drug for controlling mortality in certain species of freshwater-reared fish.

Paqflor contains the same active ingredient (florfenicol) as the approved brand name drug product, Aquaflor, which was first approved on October 24, 2005. In addition, the FDA determined that Paqflor contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.

Over the past several decades, the FDA has implemented policies to help ensure that medically important antimicrobials approved for use in animals, including fish, are used in a manner that is consistent with principles of antimicrobial stewardship. For example, all medically important antimicrobials for animals require the oversight of a licensed veterinarian because the FDA believes that, given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance. Paqflor is a veterinary feed directive drug and only available by or on the order of a licensed veterinarian.

View NOAA's Antibiotic Use in Finfish Fact Sheet

The FDA also assessed the safety of edible products from fish treated with Paqflor and determined that, when used according to the labeling, any residues of florfenicol that remain in the edible tissues of treated fish are at a concentration that meet the agency’s standard of reasonable certainty of no harm to people eating the fish.

Environmental assessments prepared for the brand name drug product, Aquaflor, resulted in the FDA concluding that no significant environmental impacts were expected from the approved uses of Aquaflor. The FDA established acute and chronic water quality benchmarks to protect freshwater aquatic life and included these on the labeling of Aquaflor for use by permitting authorities. Paqflor is marketed under the same conditions of approval as Aquaflor, and the labeling for Paqflor contains the same language dictating how it can be used.

Paqflor is sponsored by Phibro Animal Health Corp. based in Teaneck, New Jersey.