Change first sentence to: Terramycin 200® for fish is an aquaculture premix containing oxytetracycline dehydrate (OTC) and is available through Syndel USA. OTC medicated feed can be purchased from aquaculture feed mills. OTC medicated feed can be used to treat bacterial diseases or to apply a skeletal mark on the fish. The primary goal of field studies conducted under INAD #9332 is to generate additional OTC-medicated feed efficacy data which can be used to expand the existing OTC label claims. Five treatment options are allowed, and disposition of investigational animals (including withdrawal times) vary with treatment regimen. The treatment regimen most frequently used by Investigators is to administer OTC in feed at 2.5 – 3.75 g active drug/100 lbs fish/day for 10 consecutive days. All labeled use must follow the approved label and go through the Veterinary Feed Directive. This INAD is limited to specific marine and freshwater fish species (the food-use authorization located in the study protocol contains a list of all species that can be treated). To participate in the INAD Program for OTC medicated feed 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 pivotal data needed to establish the effectiveness of oxytetracycline (OTC) when fed as a feed additive to 1) control mortality caused by bacterial diseases in a variety of freshwater and marine fish, and abalone; and 2) mark skeletal tissue of finfish.
Oxytetracycline dihydrate (Terramycin 200® for Fish; TM200)
1441 W Smith Rd
Ferndale, WA 98248 USA
Target pathogen(s): Bacterial pathogens susceptible to oxytetracycline, exclusive of already approved claims.
Method of administration: Medicated feed treatment
Investigational Withdrawal period:
Required test parameters:
Limitations or restrictions on use of drug:
Required INAD fee: $700/facility/year
AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP