Posted by Michael Wonder on 11 Aug 2020
Fennec Pharmaceuticals receives complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic, solid tumours
11 August 2020 - FDA pre-approval inspection has identified deficiencies with the facility of the drug product manufacturer, which require resolution prior to Pedmark approval.
Fennec Pharmaceuticals today announced that it received a complete response letter on 10 August 2020 from the U.S. FDA regarding its new drug application for Pedmark (a unique formulation of sodium thiosulphate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in paediatric patients ≥1 month to 18 years of age with localised, non-metastatic, solid tumours.
