Complete Response Letter for Pedmark for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors. Fennec Pharma

Fennec Pharmaceuticals Inc., announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the FDA regarding its New Drug Application (NDA) for Pedmark(a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients greater than 1 month to 18 years of age with localized, non-metastatic, solid tumors. According to the CRL, after recent completion of a pre-approval inspection of the manufacturing facility of the drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of conditions or practices that are required to be resolved prior to the approval of Pedmark. The Company plans to request a Type A meeting to discuss the issues and other matters that were described in the CRL pertaining to the steps required for the resubmission of the NDA for Pedmark. Importantly, no clinical safety or efficacy issues were identified during the review and there is no requirement for further clinical data.