Halamid® Aqua gains exclusive animal drug status in the USA

AxcentiveArchive

Axcentive is proud to announce the imminent award of a New Animal Drug Application (NADA) approval for the use of Halamid® in aquaculture in the USA; such approval to be granted by FDA’s Center for Veterinary Medicine.

All technical sections for this application have been completed and the remaining administrative procedure is expected to take another 2 months. The product will be marketed in the US as Halamid® Aqua and is available in 25 kg drums and 5 kg buckets.

The approval will cover treatment of freshwater reared salmonids, walleye and freshwater-reared warm water finfish; either for bacterial gill disease or external columnaris disease.

A key factor in the success of this project has been the cooperation between many agencies, organizations such as the Federal-State Aquaculture Drug Approval Partnership , the US Fish and Wildlife Service, the Upper Midwest Environmental Sciences Center, the National NADA Coordinator and Axcentive. Either alone or together in project teams, they took care of the generation of efficacy tests, target animal safety data, analytical methodology, product labeling , human food safety data, environmental assessment and safety requirements etc.