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Crop Biotech Update

FDA Approves Application for AquaBounty Salmon Facility in Indiana, USA

May 2, 2018

The U.S. Food and Drug Administration (FDA) has approved a supplemental New Animal Drug Application (NADA) submitted by AquaBounty Technologies, Inc. that requests FDA approval to raise AquAdvantage Salmon – a product under an application previously approved in 2015 – at a land-based contained facility near Albany, Indiana.

While the Indiana facility is approved for production, the company is prohibited from importing the eggs necessary for producing genetically engineered (GE) salmon at the facility because of a requirement in FDA's current appropriations law. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is required to review NADAs for safety and effectiveness. AquaBounty met these and other statutory requirements, so the FDA approved the supplemental application.

For more information, read the update from the FDA's Center for Veterinary Medicine.