Posted by Michael Wonder on 22 Jun 2021
Fennec Pharmaceuticals announces FDA acceptance of new drug application resubmission for Pedmark
22 June 2021 - Prescription Drug User Fee Act target action date set for 27 November 2021.
Fennec Pharmaceuticals today announced that the U.S. FDA has accepted for filing the resubmission of its new drug application for Pedmark (a unique formulation of sodium thiosulphate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localised, non-metastatic, solid tumours.
