FDA Approves Label Extensions Making Syndel’s Parasite-S the Only Formalin Product Approved for Control of Fungus on Freshwater Finfish
FERNDALE, WA, September 12, 2019—Parasite-S (formalin) has new label indications in the US permitting its use as a fungicide on all freshwater-reared finfish. According to Chris McReynolds, Syndel CEO, “Syndel is proud of the FDA’s recognition that our Parasite-S safely meets the needs of all state, federal, and private freshwater finfish facilities for the treatment of fungus on fish. This demonstrates our ongoing commitment to supporting aquaculture’s contribution to the world’s growing demand for safe and healthy protein.”
Syndel’s formalin product, Parasite-S, long an FDA approved treatment for control of fungi of the family Saprolegniaceae in freshwater finfish eggs, is now approved by the FDA for treatment of saprolegniasis associated with Saprolegniaceae fungi on fish themselves. Syndel’s Parasite-S is the only legal FDA approved formalin product for this treatment in the US.
In addition, Syndel worked with the FDA to establish water quality benchmarks for the protection of freshwater aquatic life, derived by Hohreiter and Rigg, 2001 (Chemosphere 45:471-486) following EPA guidelines. This NEW specific benchmark provides realistic and measurable guidelines that facilities can share with their local NPDES local discharge permit writers to demonstrate compliance.
AADAP ANNOUNCEMENT — “In April 2019, Syndel announced an indication addition for Parasite- S (formalin). The new indication allows use of Parasite-S to control mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae when administered at a dose of 150 ppm for 60 minutes per day on alternate days for three treatments in tanks and raceways. For more information on dosing, limitations, and treatment calculations of other Parasite-S (formalin) indications, refer to AADAP’s Quick Desk Reference Guide to Approved Drugs for Use in Aquaculture.
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 headquarters are located in the beautiful Pacific Northwest near Ferndale, Washington, USA (including our quality control laboratories, and FDA inspected manufacturing plant), and a Canadian office located in Nanaimo, BC, Canada.
For more information about Parasite-S, producers should contact their veterinarian, diagnostician, Syndel representative, or go to https://syndel.com/. In the US, information is also available at https://syndel.com/product/parasite-s-formalin/. Always consult the label for indications approved in your local market.
For the FDA Freedom of Information Summary on the Supplemental Approval for Parasite-S, visit: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7011