FDA approval of first US facility for commercial production of AquAdvantage Salmon

Photo: AquaBounty

AquaBounty Technologies, Inc. a biotechnology company focused on enhancing productivity in the aquaculture market and a majority-owned subsidiary of Intrexon Corporation, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to raise AquAdvantage® Salmon at its land-based contained facility near Albany, Indiana.

The FDA previously approved AquaBounty’s New Animal Drug Application (NADA) on November 19, 2015, for the production, sale, and consumption of AquAdvantage Salmon in the United States. That approval specified that all production facilities for the product would require separate site-specific approvals. To conform with this requirement, the Company submitted a supplementary NADA to the FDA requesting approval to grow AquAdvantage Salmon at its farm site near Albany, Indiana. The Indiana facility as currently configured has a production capacity of 1200 tons per year and was designed to allow significant expansion. With the facility now approved, commercial production of AquAdvantage Salmon awaits only official labeling guidelines by the FDA.

AquaBounty CEO Ron Stotish stated, “This is another milestone in our journey to bring our healthy and sustainable salmon to consumers. We are very pleased the FDA has continued their rigorous science-based review process and approved our application on its merits. Our Albany facility is within a few hours’ drive of major markets in Indianapolis, Chicago, Detroit, Cleveland, Columbus, Louisville, and St. Louis, providing us with tremendous opportunity for growth. We still have work to do before we can start production, but we take great pride in this latest accomplishment.”

Shannon Henry, Delaware County Commissioner, added, “We are extremely excited that a cutting-edge aquaculture company like AquaBounty chose Delaware County to grow their operation. The jobs being created at this facility and large capital investment is welcomed news. We will continue to support their efforts.”

About AquAdvantage Salmon – AquAdvantage Salmon is an Atlantic salmon that has been enhanced to grow to market size in about half the time of a traditional farmed Atlantic salmon. It is grown only in land-based contained facilities using a sterile, all-female population. AquAdvantage Salmon is a healthy, environmentally sustainable alternative to conventional farmed Atlantic salmon.

More information about AquaBounty is available at www.aquabounty.com.