Letters from CVM responding to AADAP submissions ...

AQUI-S®

Status of effectiveness technical section (coolwater species) - 28 November 06

Status of effectiveness technical section (salmonids) - 28 November 06

Status of effectiveness technical section (warmwater species) - 28 November 06

Acceptance of rainbow trout target animal safety study - 8 December 06

Acceptance of blue catfish life-stage preliminary safety study - 16 February 07

Acceptance of largemouth bass pilot safety study - 27 April 07

Review of Freedom of Information Summary content - 10 July 07

Acceptance of cutthroat trout target animal safety study -10 January 2008

Chloramine-T

Concurrence with pivotal efficacy protocol for BGD/external columnaris - 26 July 07

EFF technical section complete for external columnaris & walleye - 3 March 08

Acceptance of external columnaris and largemouth bass pivotal efficacy study -
14 April 07

Rejection of pivotal efficacy Final Study Report suporting claim for the control of mortality in largemouth bass caused by external columnaris - 23 May 2008

Aquaflor® (florfenicol)

Rejection as pivotal, but acceptance as supportive efficacy study on cutthroats & coldwater disease - 8 February 02

Rejection as pivotal, but acceptance as supportive efficacy study on cutthroats & coldwater disease - 4 October 02

Acceptance of cutthroat EFF data for coldwater disease in FW salmonids - 4 March 03

Acceptance of rainbow EFF data for coldwater disease in FW salmonids - 10 June 03

EFF technical section complete for coldwater disease & FW salmonids - 7 August 03

EFF technical section complete for furunculosis in FW salmonids - 19 April 07

EFF technical section complete for Streptococcus iniae in hybrid striped bass -
4 April 2008

17-α methyltestosterone (MT)

Acceptance of one EFF pivotal study for MT in tilapia - 27 July 07

EFF technical section incomplete for MT in tilapia - 1 May 2008

Proposal to accept data from any strain/subspecies of Oncorhynchus mykiss as representing the species

Acceptance of proposal - 25 July 07

35% Perox-Aid® (hydrogen peroxide)

Rejection of INAD efficacy protocol - 13 November 2007

Acceptance of INAD efficacy protocol - 6 February 2008

Oxytetracycline medicated feed

Acceptance of EFF data for coldwater disease in all FW salmonids and systemic columnaris in FW steelhead trout - 31 December 2003

 
 
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