Posted by Michael Wonder on 29 Apr 2022
Fennec Pharmaceuticals announces FDA acceptance for filing of new drug application resubmission for Pedmark
27 April 2022 - Prescription Drug User Fee Act target action date set for 23 September 2022.
Fennec Pharmaceuticals today announced that the U.S. FDA has accepted for filing the Company’s resubmitted new drug application 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.
