Posted by Michael Wonder on 24 Mar 2022
Fennec Pharmaceuticals resubmits new drug application to the U.S. FDA for Pedmark
24 March 2022 - Fennec Pharmaceuticals today announced the resubmission of its new drug application to the U.S. FDA for Pedmark (a unique formulation of sodium thiosulphate) for the prevention of platinum-induced ototoxicity in paediatric patients one month to <18 years of age with localised, non-metastatic, solid tumours.
“We appreciate the FDA’s comments during the resubmission process and look forward to working closing with the Agency during the NDA review,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “We are pleased to have reached this important step and Fennec remains committed to making Pedmark available to reduce the risk of cisplatin induced ototoxicity in paediatric patients.”
