It is a unique partnership between the drug suppliers, the Fish and Wildlife Service, the FDA, various universities and many others with the focus on having proper regulatory coverage for an aquaculture industry that is too small to support the extensive testing and dossier preparation a FDA New Animal Drug Approval (NADA) requires.
Halamid® Aqua is a well-known name within the AADAP as in the early nineties it was one of the first products to be recognised as a drug of importance to the US aquaculture industry. Thanks to the support of many local organizations and the continuous support of Axcentive, in 2014 an official FDA approval for Halamid® Aqua was received.
On June 9 and 10, the AADAP held its annual conference, this time in Jackson, Wyoming. Two days of exchange of information and experiences with for the first time, Axcentive physically present. Paul van Lenthe explains why: A new animal drug approval is the result of an extensive process of designing test protocols, field testing, lobbying, looking for funds, building a dossier, and so on. The potential market in aquaculture for most drugs is simply too small to economically justify the kind of testing the FDA requires.
A partnership such as AADAP has been essential to bring together testing institutes, suppliers, the FDA, funding, etc. Our local consultants, our distributor and other stakeholders having an interest in showing that an approved aquaculture drug is possible, have driven much of this process in close contact with us. For Axcentive the trajectory was clear, the NADA was the first stop but… without time table.
With the NADA in hand, Axcentive can now take more control. Not only in terms of marketing but also to enrich the basic claims with useful new designations allowing fish farmers and state hatcheries to use Halamid® Aqua for a wider range of (bacterial) diseases that affect both welfare and economical revenues. It was a valuable motivating experience to be at the spot and meeting many of the people that have been critically important in the approval process. It motivates us to work even closer with AADAP and help making a continued success of this Program.
Work has started on setting up new designations and although these are again long processes, Axcentive are confident that Halamid® Aqua will continue to have support in the AADAP as it is in everybody’s interest to have the means to keep fish healthy.
Further information can be obtained from local Halamid distributors or www.halamid.com.
