Florfenicol Studies...

Efficacy Studies

In order to complete this technical section, CVM's Aquaculture Team requires acceptance of 2 - 4 pivotal studies for a particular label claim. Listed below is the status of these studies, please click on a study location to see the Final Study Report that has been submitted to CVM.

Information last updated: 6 January 2012

Freshwater-Reared Salmonids

Pivotal Studies

Bacterial Coldwater Disease (efficacy technical section completed)

Steelhead - Makah National Fish Hatchery (Washington)

Final Study Report (FLOR-01-EFF-06) submitted to CVM 9 Sep 2002

CVM acceptance response received 4 Mar 2003

Cutthroat trout - Washoe Park Trout Hatchery (Montana)

Final Study Report (FLOR-01-EFF-12) submitted to CVM 7 Jan 2003

CVM acceptance response received 10 Jun 2003

Furunculosis (efficacy technical section completed!)

Chinook salmon - Makah National Fish Hatchery (Washington)

Final Study Report (FLOR-01-EFF.3-22) submitted to CVM 3 Jan 2005

CVM acceptance response received 26 Aug 2005

Coho salmon - Makah National Fish Hatchery (Washington)

Final Study Report (FLOR-01-EFF.3-27) submitted to CVM 29 Nov 2006

CVM acceptance response received 19 Apr 2007

Columnaris ("technical section completed" response pending)

Coho salmon - Bellingham State Fish Hatchery (Washington)

Final Study Report (FLOR-01-EFF-08) submitted to CVM 18 Nov 2002

CVM acceptance response received 21 Apr 2003

Rainbow trout - Bellingham State Fish Hatchery (Washington)

Final Study Report (FLOR-01-EFF.3-33) submitted to CVM 9 Dec 2008

CVM rejection of study as pivotal, but accepted as supportive received 29 May 2009

Bacterial Kidney Disease (technical section incomplete)

Chinook salmon - Eagle Fish Health Lab, Idaho

Final Study Report (AQFLR-09-EFF-02)
submitted to CVM 26 April 2011

Final Study Report (AQFLR-09-EFF-04)
submitted to CVM 27 April 2011

CVM acceptance response for both AQFLR-09-EFF-02 and AQFLR-09-EFF-04 received 23 June 2011

Supportive Studies

Bacterial Coldwater Disease (all studies accepted as supportive)

Cutthroat trout - Washoe Park Trout Hatchery (Montana)

Final Study Report (FLOR-01-EFF-03) submitted to CVM 12 Dec 2001

CVM acceptance response received 8 Feb 2002

Cutthroat trout - Murray Springs State Fish Hatchery (Montana)

Final Study Report (FLOR-01-EFF-04) submitted to CVM 5 Feb 2003

CVM acceptance response received 7 Aug 2003

Cutthroat trout - Bozeman Fish Technology Center (Montana)

Final Study Report (FLOR-01-EFF-05) submitted to CVM 10 Apr 2002

CVM acceptance response received 4 Oct 2002

Furunculosis (all studies accepted as supportive)

Coho salmon - Makah National Fish Hatchery (Washington)

Final Study Report (FLOR-01-EFF-01) submitted to CVM 19 Dec 2001

CVM acceptance response received 1 Feb 2002

Coho salmon - Makah National Fish Hatchery (Washington)

Final Study Report (FLOR-01-EFF-09) submitted to CVM 30 Sep 2002

CVM acceptance response received 12 Mar 2003

Columnaris (accepted as supportive)

Final Study Report (AQFLR-09-EFF-03) submitted to CVM 17 August 2011

CVM response letter received 2 September 2011

Hybrid Striped Bass

Pivotal Studies

Streptococcus iniae (efficacy technical section completed)

Hybrid striped bass - Kent SeaTech, Corp. (California)

Final Study Report (FLOR-01-EFF-02.b) submitted to CVM 10 Feb 2003

CVM acceptance response received 15 Aug 2003

Hybrid striped bass - Kent SeaTech, Corp. (California)

Final Study Report (FLOR-01-EFF.3-19) submitted to CVM 23 Feb 2004

CVM acceptance response received 9 Dec 2004

Warmwater species of freshwater finfish

Pivotal Studies

Systemic columnaris (technical section incomplete)

Largemouth bass - Richloam Fish Hatchery (Florida)

Final Study Report (FLOR-01-EFF.3-35) submitted to CVM 4 August 2009

CVM acceptance response received 29 January 2010

Bluegill - Richloam Fish Hatchery (Florida)

Final Study Report (AQFLR-09-EFF-01) submitted to CVM 2 February 2010

CVM acceptance response received 29 July 2010

Target Animal Safety Studies

In order to complete this technical section, CVM's Aquaculture Team requires acceptance of minimally 2 pivotal studies for a particular label claim (e.g., all cold water finfish). Listed below is the status of these studies, please click on a study location to see the Final Study Report that has been submitted to CVM.

Pivotal Studies

Sunshine Bass (Female White Bass Morone chrysops x Male Striped Bass M. saxatilis) - Stuttgart National Aquaculture Research Lab (Arkansas)

Final Study Report (FLOR-08-TAS-SSB-01) submitted 13 January 2010

CVM acceptance response received 8 July 2010

Yellow Perch (Perca flavescens) - Bozeman Fish Technology Center (Montana)

Final Study Report ( FLOR-08-TAS-YP.1-01) submitted 13 August 2010

CVM acceptance response received 10 February 2011

 

 

 

 

 

 

 

 
 
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LAST UPDATED: 16-Jan-2013