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 07Acceptance of cutthroat trout target animal safety study -10 January 2008
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
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 07EFF 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
35% Perox-Aid® (hydrogen peroxide)
Oxytetracycline medicated feed