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.
Merck Animal Health
35500 W. 91st Street
De Soto, KS 66018
Kasha M. Cox
Target pathogen(s): Bacterial pathogens susceptible to florfenicol, exclusive of already approved claims.
Method of administration: Medicated feed treatment
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.
Required test parameters:
Limitations or restrictions on use of drug:
Not for use for existing FDA-approved claims for florfenicol.
Required INAD fee: $700/facility/year
AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP