Posted by Michael Wonder on 01 Dec 2021
Fennec Pharmaceuticals receives complete response letter from the US FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic, solid tumours
30 November 2021 - Fennec Pharmaceuticals today announced that it received a complete response letter on 29 November 2021 from the U.S. FDA, after the PDUFA target action date of 27 November 2021, 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.
The complete response letter was issued as a result of identified manufacturing deficiencies which need to be satisfactorily resolved before the Pedmark new drug application can be approved.
