Fish and Aquatic Conservation


Florfenicol (Aquaflor®) INAD #10-697

Juvenile atlantic salmon in Scatter Creek, Washington. Credit: Roger Tabor/USFWS

Summary

Aquaflor® is an aquaculture premix containing florfenicol and is only available through Merck Animal Health. The primary goal of field studies conducted under INAD #10-697 is to evaluate the efficacy of florfenicol-medicated feed for controlling mortality in a variety of fish species diagnosed with a variety of diseases that are caused by pathogens susceptible to florfenicol. Aquaflor® medicated feed can be purchased through aquaculture feed mills. For example, diseases of interest include, but are not limited to, (a) enteric redmouth, (b) bacterial hemorrhagic septicemia caused by Aeromonads and Pseudomonads, and (c) Aeromonas Hydrophila. INAD use is for non-labeled use only. All labeled use must follow the approved label and go through the Veterinary Feed Directive. The treatment options that are allowed to administer Aquaflor® in feed is 10 or 15 mg active florfenicol/kg fish/day for 10 consecutive days, and the Investigational withdrawal period for salmonids is 15 days for freshwater-reared finfish; 15 days for saltwater-reared finfish at 10 mg/Kg body weight for 10 consecutive days; or 28 days for saltwater-reared finfish treated between 10 – 15 mg/Kg body weight for 10 consecutive days. To participate in the INAD Program for Aquaflor® visit the data collecting site.

Please read the Study Protocol prior to any treatments. It contains the protocol, MSDS, and a copy of the forms to be used as a guide for collecting data that will be entered into the online INAD database. The FDA authorization letter(s) for this INAD is currently only available by emailing Bonnie Johnson .


INAD objective/purpose: Collect supportive and/or pivotal data needed to establish the effectiveness of florfenicol to control mortality caused by certain bacterial diseases.

Drug Name
Florfenicol (Aquaflor®)

Drug Source
Merck Animal Health
35500 W. 91st Street
De Soto, KS 66018

Kasha M. Cox
Phone: 662-907-0692
kasha.cox@merck.com

Target pathogen(s): Bacterial pathogens susceptible to florfenicol, exclusive of already approved claims.

Method of administration: Medicated feed treatment

Treatment dosage:

  • 10 or 15 milligrams (mg) florfenicol per kilogram (kg) fish body weight per day

Treatment regimen:

  • 10 consecutive days

Investigational Withdrawal period:

  • 15 days for freshwater-reared finfish

  • 15 days for saltwater-reared finfish at 10 mg/Kg body weight for 10 consecutive days.

  • 28 days for saltwater-reared finfish treated between 10 – 15 mg/Kg body weight for 10 consecutive days.

Required test parameters:

  • Investigator must collect mortality data throughout the 5 day pre-treatment, treatment, and 10 day post-treatment periods. Investigator should also report general fish behavior and any adverse effects relating to treatment.

Limitations or restrictions on use of drug:

  • Not for use for existing FDA-approved claims for florfenicol.

  • Investigator must follow all instructions in the Study Protocol for INAD 10-697 regarding drug acquisition and handling, fish treatment and disposition, and data reporting requirements.
  • Drug discharge must be in compliance with local NPDES permitting requirements.

Required INAD fee: $700/facility/year

AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP
Phone: 406-994-9905
email: bonnie_johnson@fws.gov