FDA Approves Additional Uses for Syndel 35% PEROX-AID® to improve fish health in freshwater finfish.
Media Contact: Chris McReynolds, CEO Syndel firstname.lastname@example.org
|Existing Treatments||Extension (additional treatments)|
|Control of mortality due to Saprolegniasis in freshwater finfish eggs.||Control of mortality due to Saprolegniasis in freshwater finfish eggs, and all coldwater finfish (including all salmonids) and all fingerling and adult coolwater and warmwater finfish.|
|Control of the mortality due to external columnaris disease associated with Flavobacterium columnare in freshwater reared coolwater finfish and channel catfish||Control of the mortality due to external columnaris disease associated with Flavobacterium columnare in freshwater reared coolwater finfish, channel catfish and warm-water finfish, including hybrid catfish and blue catfish.|
|Control of the mortality due to Bacterial Gill Disease associated with Flavobacterium branchiophilum in freshwater salmonids||Control of the mortality due to Bacterial Gill Disease associated with Flavobacterium branchiophilum and for the control of Gyrodactylus spp. in freshwater-reared salmonids|
SYNDEL Ferndale, Wa — “Our goal with these label extensions is to fill an unmet need by providing government, commercial hatcheries and other fish production facilities with legal options for protecting fish from common health concerns. Freshwater salmonid facilities run the risk of the parasite Gyrodactylus, which causes mortality and reduced growth. The lack of options for treating fungus on fish has historically resulted in aquaculture facilities resorting to using treatments that are less than ideal, and our product provides hatcheries with an approved option for treating fish. Ultimately, our aim is to support hatchery efforts to meet the world’s growing food demand with safe and healthy options. We would also like to thank our Federal partners at UMESC and FDA CVM’s Office of Research for their efforts to generate the supporting data” Syndel CEO Chris McReynolds said.
FDA PRESS RELEASE — “This approval will help provide a critical treatment for improving fish health. The agency also anticipates that resource management agencies will use this approved treatment for aiding in the restoration of certain freshwater fish populations.” The new product indications address disease concerns identified by aquaculture facilities in the US FWS Aquatic Animal Drug Approval Partnership’s Unmet Fish Drug Needs Survey.
For the FDA Freedom of Information Summary on the Supplemental Approval for 35% PEROX-AID®, visit: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7407
ABOUT SYNDEL— Syndel is a privately held company that has developed and marketed high quality aquaculture pharmaceutical health and nutritional products worldwide for more than 40 years. Syndel has headquarters located in Ferndale, Washington, USA (including our quality control laboratories, and FDA inspected manufacturing plant) and a Canadian office located in Nanaimo, BC, Canada. www.syndel.com