Halamid® Aqua Gains Exclusive Animal Drug Status06 May 2014
US - The US Food and Drug Administration’s Center for Veterinary Medicine (CVM) has awarded a New Animal Drug Application (NADA) approval to Axcentive for the use of Halamid® Aqua in aquaculture throughout the USA.
The approval covers three label claims: control of mortality in (1) all freshwater-reared salmonids due to bacterial gill disease, (2) walleye due to external columnaris disease and (3) all freshwater-reared warm water finfish due to external columnaris disease. Halamid® Aqua is available in 25 kg drums and 5 kg buckets.
Paul Raadsen, Executive Director at Axcentive commented: “A key factor in the success of this project has been the cooperation between many agencies and organizations such as the Federal-State Aquaculture Drug Approval Partnership Project, the Aquatic Animal Drug Approval Partnership Program, the Upper Midwest Environmental Sciences Center, the National NADA Coordinator (currently Roz Schnick Consulting, LLC) and Axcentive.”
The sponsor, Axcentive Sarl, funded a part of the studies done by other research institutes, completed the requirements for toxicology, environmental safety, microbial food safety, and chemistry, manufacturing and controls. After many years of effort, Axcentive completed the requirements for all major and minor technical sections which led to the final submission and approval of the Administrative NADA.
Paul Raadsen continued: “This is an important approval for the US aquaculture industry. Halamid® Aqua will be:
• The second waterborne drug approved for disease claims for finfish in almost 30 years
• The third aquaculture drug with an original approval covering multiple label claims for use in a variety of finfish species, and
• The fourth aquaculture drug to gain NADA approval under the Minor Use and Minor Species Animal Health Act, entitling Axcentive SARL to seven years of exclusive marketing rights for the approved label claims.
All participants involved are to be congratulated for their major contributions to this significant approval.
"A very special thank you goes to past and current staff at CVM for the tremendous guidance they provided and the encouragement they gave us while we were going through the approval process.”
TheFishSite News Desk