Posted by Michael Wonder on 13 Apr 2020
Fennec Pharmaceuticals announces FDA filing acceptance and priority review of new drug application for Pedmark
13 April 2020 - FDA grants priority review and sets a Prescription Drug User Fee Act target action date of 10 August 2020.
Fennec Pharmaceuticals announced today that the U.S. FDA has accepted for filing and granted priority review for the company’s new drug application for Pedmark (a unique formulation of sodium thiosulphate).
Pedmark is an investigational drug for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localised, non-metastatic, solid tumours.
