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2022-04-28| In-Depth

Fennec Submits Hearing Loss Drug for Third Time After Prior FDA Approval Rejections

by Reed Slater
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Fennec’s PEDMARK is designed to prevent ototoxicity in patients aged one month to 18 years old using a novel formulation of sodium thiosulfate. Through clinical trials, Fennec says that PEDMARK is most effectively administered in an intravenous bolus dose within six hours of chemotherapy treatment. 

Despite receiving numerous regulatory milestones and praise after successful clinical trials, Fennec struggles to receive FDA approval for its seemingly promising drug. 

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