Fact Sheet: Florfenicol INAD 10-697

for detailed information, see INAD study protocol, use link on the left

last updated: 1 December 2011

The following links are specific to:
Florfenicol

Drug summary & history

List of FDA-Approved drugs

Drug forms to be completed

Examples of completed forms

INAD study protocol

Material Safety Data Sheet
(MSDS)

Study Summaries

What's the status of this drug's approval

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Sign-up via the INAD Program Management System (IPMS)

Information on EPA's National Pollutant Discharge Elimination System (NPDES) Permits

Procedure for processing Florfenicol-medicated feed using Aquaflor® Premix

Authorization & Categorical Exclusion Letters

Objective/purpose: Collect supportive and pivotal data needed to establish the effectiveness of florfenicol to control mortality caused by certain bacterial diseases.
Drug name: Florfenicol (Aquaflor®)
Source of drug: Merck Animal Health
Address: 556 Morris Avenue
Summit, NJ 07901
Contact:

Richard Endris, PhD
Phone: 908-473-5618; Fax: 908-473-5560;
email: richard.endris@merck.com

Target pathogen(s): Bacterial pathogens susceptible to florfenicol, exclusive of already approved claims (i.e., Edwardsiella ictaluri and Flavobacterium columnare in catfish, and Aeromonas salmonicida and Flavobacterium psychrophilum in freshwater-reared salmonids).
Method of administration: Medicated-feed treatment
Treatment dosage: 10 or 15 milligrams florfenicol per kilogram fish body weight
per day
Treatment regimen:

10 days (consecutive)

Withdrawal period:

21 days (all salmonids)

28 days (all non-salmonids)

No withdrawal period is required for fish that are not susceptible to legal harvest for a period posttreatment equal to the withdrawal periods noted above or are illegal for harvest during those same periods.

Required test parameters: Investigator must collect mortality data throughout the 10-day pre-treatment, treatment, and 21-day posttreatment period. Investigator should also report general fish behavior and any adverse effects relating to treatment.
Limitations or restrictions on use:

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: $400.00 per facility per year
AADAP contact for other information: Ms. Bonnie Johnson, FWS - AADAP
Phone: 406-994-9905
Fax: 406-582-0242

bonnie_johnson@fws.gov
Disclaimer: Product and company names mentioned in this website, or mentioned in materials accessed via this website, are for informational purposes only. The mention of such does not imply endorsement by the Aquatic Animal Drug Approval Partnership, the U.S. Fish & Wildlife Service or any other organization of the U.S. Government.