| 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
Print
this drug fact sheet
Print
all drug fact sheets
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. |
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