Posted by Michael Wonder on 23 Dec 2018
Fennec Pharmaceuticals initiates rolling submission new drug application to US FDA for Pedmark
20 December 2018 - Pedmark is proposed to be indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.
Fennec Pharmaceuticals has initiated a rolling new drug application for Pedmark (a unique formulation of sodium thiosulphate to be administered by infusion) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours. The Company is targeting U.S. approval of Pedmark in the second half of 2019.
Pedmark has been granted orphan drug, breakthrough therapy and fast track designations from the FDA.
