Fennec Pharma expects a Complete Response Letter from the FDA for Pedmark.
Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced that it expects to receive a Complete Response Letter (CRL) after the PDUFA target action date of November 27, 2021 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.