Fennec Pharmaceuticals Inc. (NASDAQ:FENC) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing of resubmitted New Drug Application (NDA) for PEDMARKTM (sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.
The regulatory agency has set a target action date of September 23, 2022.
