Following up on their NDA resubmission, Fennec Pharmaceuticals has been granted U.S. Food and Drug Administration (FDA) approval for its unique formulation of sodium thiosulfate called PEDMARK™. PEDMARK™ is meant to prevent ototoxicity in patients between one month and 18 years of age that have non-metastatic, localized solid tumors caused by cisplatin chemotherapy. CEO of Fennec Pharmaceuticals, Inc., Rosty Raykov, stated, “We are pleased that the FDA has accepted our PEDMARK™ resubmission. We look forward to working closely with the FDA through the review process. We are committed to bringing this treatment to children receiving cisplatin chemotherapy, an area of high unmet medical need. If approved, PEDMARK™ stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients.”
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