Posted by Michael Wonder on 11 Feb 2020
Fennec Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for Pedmark and also submits marketing authorisation application to EMA
11 February 2020 - Pedmark is being developed for prevention of cisplatin-induced hearing loss in children.
Fennec Pharmaceuticals today announced it has completed its rolling submission of a new drug application to the U.S. FDA for Pedmark (a unique formulation of sodium thiosulfate) for intravenous use and submitted a marketing authorisation Application to the EMA for sodium thiosulfate (tradename to be determined).
The Pedmark indication requested is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localised, non-metastatic, solid tumours.
