Posted by Michael Wonder on 29 Nov 2021
Fennec Pharmaceuticals expects to receive 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
29 November 2021 - FDA pre-approval inspection identified deficiencies with the facility of the drug product manufacturer, which require resolution prior to Pedmark approval.
Fennec Pharmaceuticals today announced that it expects to receive a complete response letter after the PDUFA target action date of 27 November 2021 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.
